The Finnish Diabetes Prevention Study. Effects of a healthy Nordic diet on cardiovascular risk factors in hypercholesterolaemic subjects: a randomized controlled trial (NORDIET). Beneficial Effect of Low-Glycemic Index Diet in Overweight NIDDM Subjects Dietary fiber and the glycemic index: a background paper for the Nordic Nutrition Recommendations 2012 Effects of varying carbohydrate content of diet in patients with non-insulin-dependent diabetes mellitus. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. 
The effect of consumption of low-glycemic-index and low-glycemic-load desserts on anthropometric parameters and inflammatory markers in patients with type 2 diabetes mellitus Dietary strategies for patients with type 2 diabetes in the era of multi-approaches; review and results from the Dietary Intervention Randomized Controlled Trial (DIRECT). Prospective Randomized Controlled Trial to Evaluate Effectiveness of Registered Dietitian–Led Diabetes Management on Glycemic and Diet Control in a Primary Care Setting in Taiwan Health effect of the New Nordic Diet in adults with increased waist circumference: a 6-mo randomized controlled trial. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Effects of diet and exercise interventions on control and quality of life in non-insulin-dependent diabetes mellitus Effects of lifestyle changes including specific dietary intervention and physical activity in the management of patients with chronic hepatitis C – a randomized trial Adherence to a Healthy Nordic Food Index Is Associated with a Lower Risk of Type-2 Diabetes—The Danish Diet, Cancer and Health Cohort Study Long-term adherence to the New Nordic Diet and the effects on body weight, anthropometry and blood pressure: a 12-month follow-up study Randomized controlled trial of a new dietary education program to prevent type 2 diabetes in a high-risk group of Japanese male workers. United Kingdom Prospective Diabetes Study 24: A 6-Year, Randomized, Controlled Trial Comparing Sulfonylurea, Insulin, and Metformin Therapy in Patients with Newly Diagnosed Type 2 Diabetes That Could Not Be Controlled with Diet Therapy
The aim of the Finnish Diabetes Prevention Study is to assess the efficacy of an intensive diet-exercise programme in preventing or delaying  type 2 diabetes in individuals with impaired glucose tolerance ( IGT ) and to evaluate the effect of the programme on the risk factors of atherosclerotic vascular diseases and the incidence of cardiovascular events . In this ongoing study , a total of 523 overweight subjects with IGT based on two oral glucose tolerance tests were r and omized to either an intervention group or a control group . The main measure in the intervention group is individual dietary advice aim ed at reducing weight and intake of saturated fat and increasing intake of dietary fibre . The intervention subjects are individually guided to increase their level of physical activity .  The control group receives general information about the benefits of weight reduction , physical activity and healthy diet in the prevention of diabetes . A pilot study began in 1993 , and recruitment ended in 1998 . By the end of April 1999 there were 65 new cases of diabetes , 34 drop-outs and one death . The weight reduction was greater ( -4.6 kg ) at 1 year in the intervention group ( n = 152 ) than in the control group ( n = 143 , -0.9 kg , P < 0.0001 ) , and this difference was sustained in the second year of follow-up . At 1 year 43.4 % and at 2 years 41.8 % of the intervention subjects had achieved a weight reduction of at least 5 kg , while the corresponding figures for the control subjects were 14.0 and 12.0 % ( P < 0.001 between the groups ) . At 1 year the intervention group showed significantly greater reductions in 2 h glucose , fasting and 2 h insulin , systolic and diastolic blood pressure , and serum triglycerides . Most of the beneficial changes in cardiovascular risk factors were sustained for 2 years . These interim results of the ongoing Finnish Diabetes Prevention Study demonstrate the efficacy and feasibility of the lifestyle intervention programme OBJECTIVE the aim of this study was to investigate the effects of a healthy Nordic diet ( ND ) on cardiovascular risk factors . DESIGN AND SUBJECTS in a r and omized controlled trial ( NORDIET ) conducted in Sweden , 88 mildly hypercholesterolaemic subjects were r and omly assigned to an ad libitum ND or control diet ( subjects ' usual Western diet ) for 6 weeks . Participants in the ND group were provided with all meals and foods . Primary outcome measurements were low-density lipoprotein ( LDL ) cholesterol , and secondary outcomes were blood pressure ( BP ) and insulin sensitivity ( fasting insulin and homeostatic model assessment -insulin resistance ) . The ND was rich in high-fibre plant foods , fruits , berries , vegetables , whole grains , rapeseed oil , nuts , fish and low-fat milk products , but low in salt , added sugars and saturated fats . RESULTS the ND contained 27 % , 52 % , 19 % and 2 % of energy from fat , carbohydrate , protein and alcohol , respectively . In total , 86 of 88 subjects r and omly assigned to diet completed the study . Compared with controls , there was a decrease in plasma cholesterol ( -16 % , P < 0.001 ) , LDL cholesterol ( -21 % , P < 0.001 ) , high-density lipoprotein ( HDL ) cholesterol ( -5 % , P < 0.01 ) , LDL/HDL ( -14 % , P < 0.01 ) and apolipoprotein (apo)B/apoA1 ( -1 % , P < 0.05 ) in the ND group . The ND reduced insulin ( -9 % , P = 0.01 ) and systolic BP by -6.6 ± 13.2 mmHg ( -5 % , P < 0.05 ) compared with the control diet . Despite the ad libitum nature of the ND , body weight decreased after 6 weeks in the ND compared with the control group ( -4 % , P < 0.001 ) . After adjustment for weight change , the significant differences between groups remained for blood lipids , but not for insulin sensitivity or BP . There were no significant differences in diastolic BP or triglyceride or glucose concentrations . CONCLUSIONS a healthy ND improves blood lipid profile and insulin sensitivity and lowers blood pressure at clinical ly relevant levels in hypercholesterolaemic subjects Objectives To determine whether low-glycemic index ( GI ) diets have clinical utility in overweight patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . Research Design and Methods Six patients with NIDDM were studied on both high- and low-GI diets of 6-wk duration with metabolic diets with a r and omized crossover design . Both diets were of similar composition ( 57 % carbohydrate , 23 % fat , and 34 g/day dietary fiber ) , but the low-GI diet had a GI of 58 compared with 86 for the high-GI diet . Results Small and similar amounts of weight were lost on both diets : 2.5 kg on high-GI diet and 1.8 kg on low-GI diet . On the low-GI diet , the mean level of serum fructosamine , as an index of overall blood glucose control , was lower than on the high-GI diet by 8 % ( P < 0.05 ) , and total serum cholesterol was lower by 7 % ( P < 0.01 ) . Conclusions In overweight patients with NIDDM , reducing diet GI improves overall blood glucose and lipid control The aim of this study is to review recent data on dietary fiber ( DF ) and the glycemic index ( GI ) , with special focus on studies from the Nordic countries regarding cardiometabolic risk factors , type 2 diabetes , cardiovascular disease , cancer , and total mortality . In this study , recent guidelines and scientific background papers or up date s on older reports on DF and GI published between 2000 and 2011 from the US , EU , WHO , and the World Cancer Research Fund were review ed , as well as prospect i ve cohort and intervention studies carried out in the Nordic countries . All of the reports support the role for fiber-rich foods and DF as an important part of a healthy diet . All of the five identified Nordic papers found protective associations between high intake of DF and health outcomes ; lower risk of cardiovascular disease , type 2 diabetes , colorectal and breast cancer . None of the reports and few of the Nordic papers found clear evidence for the GI in prevention of risk factors or diseases in healthy population s , although association was found in sub-groups , e.g. overweight and obese individuals and suggestive for prevention of type 2 diabetes . It was concluded that DF is associated with decreased risk of different chronic diseases and metabolic conditions . There is not enough evidence that choosing foods with low GI will decrease the risk of chronic diseases in the population overall . However , there is suggestive evidence that ranking food based on their GI might be of use for overweight and obese individuals . Issues regarding methodology , validity and practicality of the GI remain to be clarified OBJECTIVE To study effects of variation in carbohydrate content of diet on glycemia and plasma lipoproteins in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . DESIGN A four-center r and omized crossover trial . SETTING Outpatient and inpatient evaluation in metabolic units . PATIENTS Forty-two NIDDM patients receiving glipizide therapy .  INTERVENTIONS A high-carbohydrate diet containing 55 % of the total energy as carbohydrates and 30 % as fats was compared with a high-monounsaturated-fat diet containing 40 % carbohydrates and 45 % fats . The amounts of saturated fats , polyunsaturated fats , cholesterol , sucrose , and protein were similar . The study diets , prepared in metabolic kitchens , were provided as the sole nutrients to subjects for 6 weeks each . To assess longer-term effects , a subgroup of 21 patients continued the diet they received second for an additional 8 weeks . MAIN OUTCOME MEASURES Fasting plasma glucose , insulin , lipoproteins , and glycosylated hemoglobin concentrations . Twenty-four-hour profiles of glucose , insulin , and triglyceride levels . RESULTS The site of study as well as the diet order did not affect the results . Compared with the high-monounsaturated-fat diet , the high-carbohydrate diet increased fasting plasma triglyceride levels and very low-density lipoprotein cholesterol levels by 24 % ( P < .0001 ) and 23 % ( P = .0001 ) , respectively , and increased daylong plasma triglyceride , glucose , and insulin values by 10 % ( P = .03 ) , 12 % ( P < .0001 ) , and 9 % ( P = .02 ) , respectively . Plasma total cholesterol , low-density lipoprotein cholesterol , and high-density lipoprotein cholesterol levels remained unchanged . The effects of both diets on plasma glucose , insulin , and triglyceride levels persisted for 14 weeks . CONCLUSIONS In NIDDM patients , high-carbohydrate diets compared with high-monounsaturated-fat diets caused persistent deterioration of glycemic control and accentuation of hyperinsulinemia , as well as increased plasma triglyceride and very-low-density lipoprotein cholesterol levels , which may not be desirable OBJECTIVE To describe the 1 ) lifestyle intervention used in the Finnish Diabetes Prevention Study , 2 ) short- and long-term changes in diet and exercise behavior , and 3 ) effect of the intervention on glucose and lipid metabolism . RESEARCH DESIGN AND METHODS There were 522 middle-aged , overweight subjects with impaired glucose tolerance who were r and omized to either a usual care control group or an intensive lifestyle intervention group .  The control group received general dietary and exercise advice at baseline and had an annual physician 's examination . The subjects in the intervention group received additional individualized dietary counseling from a nutritionist . They were also offered circuit-type resistance training sessions and advised to increase overall physical activity .  The intervention was the most intensive during the first year , followed by a maintenance period . The intervention goals were to reduce body weight , reduce dietary and saturated fat , and increase physical activity and dietary fiber . RESULTS The intervention group showed significantly greater improvement in each intervention goal . After 1 and 3 years , weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group , respectively . Measures of glycemia and lipemia improved more in the intervention group . CONCLUSIONS The intensive lifestyle intervention produced long-term beneficial changes in diet , physical activity , and clinical and biochemical parameters and reduced diabetes risk . This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system Abstract Purpose The aim of the present study was to examine the effects of consumption of desserts with low glycemic index ( GI ) and low glycemic load ( GL ) , as part of a balanced hypo-caloric diet , on anthropometric and biochemical parameters in patients with type 2 diabetes mellitus ( T2DM ) . Methods A total of 61 subjects with T2DM were r and omly assigned to the intervention ( n = 30 ) or to the control group ( n = 31 ) . Both groups followed the same hypo-caloric ( −500 kcal ) diet for 12 weeks . Consumption of four portions of low-GI/low-GL desserts/week was included in the diet in the intervention group while one portion of a favorite usual sweet/week was allowed to be consumed in the control group . Results Thirty subjects in the control and 28 subjects in the intervention group completed the trial . Body weight , body mass index , and waist circumference were reduced significantly in both groups . Arterial blood pressure , fasting blood glucose , glycosylated hemoglobin , insulin , and γ-GT were reduced significantly only in the intervention group ; however , there were no significant differences between the two groups at endpoint . C-reactive protein was reduced in the intervention , and HDL cholesterol was also reduced in the control group ; the reductions were significantly different at the end of the trial . No significant changes were observed in the other plasma lipids , uric acid , leptin , adiponectin , and interleukin-6 in either study group . Conclusions Consumption of desserts with low GI/GL in a balanced hypo-caloric diet has a positive impact on anthropometric and metabolic parameters of patients with T2DM Dietary intervention is recognized as a key component in prevention and management of type 2 diabetes ( T2DM ) and the debate persists : which dietary strategy is most effective . In the Dietary Intervention R and omized Controlled Trial ( DIRECT ) 322 moderately obese participants were r and omized for 2 years to one of three diet groups : low-fat , Mediterranean and low-carbohydrate . Differential effects were observed in the sub-group of patients with T2DM at 24 months : participants r and omized to the Mediterranean diet , which had the highest intake of dietary fibers and unsaturated to saturated fat ratio , achieved greater significant improvements in fasting plasma glucose and insulin levels . Patients who were r and omized to the low-carbohydrate diet , which had the minimal intake of carbohydrates , achieved a significant reduction of hemoglobin A1C . Although improvements were observed in all groups , the low-fat diet was likely to be less beneficial in terms of glycemic control and lipid metabolism . Interpretation of results from different studies on dietary strategies may be complex since there is often no consistency in diet compositions , calorie restriction , intensity of intervention , dietary assessment or extent of adherence in the trial . Nevertheless , it seems that low fat restricted calorie diets are effective for weight loss and are associated with some metabolic benefits ; however , some recent trials have shown that low carbohydrate diets are as efficient in inducing weight loss and in some metabolic measures such as serum triglycerides and HDL-cholesterol may be even superior to low fat diets . When addressing the issue of diet quality rather than quantity applying the glycemic index may have some added benefits . Furthermore special features of the Mediterranean diet have apparent additional favorable effects for patients with T2DM OBJECTIVE In this r and omized controlled trial we evaluated the effect of registered dietitian – led management of diabetes on glycemic control and macronutrient intake in type 2 diabetic patients in primary care clinics in Taiwan and studied the association between changes in macronutrient intake and glycemic measures . RESEARCH DESIGN AND METHODS We recruited 154 adult patients with type 2 diabetes and r and omly assigned them to a routine care control group ( n = 79 ) or a registered dietitian – led intervention group ( n = 75 ) who received on-site diabetic self-management education every 3 months over 12 months . RESULTS Over the 1-year period , neither the intervention group ( n = 75 ) nor the control group ( n = 79 ) had significant changes in A1C , whereas the intervention patients with poorly controlled baseline A1C ( ≥7 % ) ( n = 56 ) had significantly greater improvements in A1C and fasting plasma glucose than the control subjects ( n = 60 ) ( −0.7 vs. −0.2 % , P = 0.034 ; −13.4 vs. 16.9 mg/dl , P = 0.007 ) during the same period . We also found significant net intervention-control group differences in overall energy intake ( −229.06 ± 309.16 vs. 56.10 ± 309.41 kcal/day ) and carbohydrate intake ( −31.24 ± 61.53 vs. 7.15 ± 54.09 g/day ) ( P < 0.001 ) in patients with poorly controlled A1C . Multivariable adjusted modeling revealed an independent association between changes in carbohydrate intake and A1C in the intervention group ( n = 56 ; β = 0.10 , SEM = 0.033 , P = 0.004 ) . CONCLUSIONS On-site registered dietitian – led management of diabetes can improve glycemic control in patients with poorly managed type 2 diabetes in primary care clinics in Taiwan . A reduction in carbohydrate intake may improve glycemic status BACKGROUND The regional Mediterranean Diet has been associated with lower risk of disease . OBJECTIVE We tested the health effects of the New Nordic Diet ( NND ) , which is a gastronomically driven regional , organic , and environmentally friendly diet , in a carefully controlled but free-living setting . DESIGN A total of 181 central ly obese men and women , with a mean ( range ) age of 42 y ( 20 - 66 y ) , body mass index ( in kg/m(2 ) ) of 30.2 ( 22.6 - 47.3 ) , and waist circumference of 100 cm ( 80 - 138 cm ) were r and omly assigned to receive either the NND ( high in fruit , vegetables , whole grains , and fish ) or an average Danish diet ( ADD ) for 26 wk . Participants received cookbooks and all foods ad libitum and free of charge by using a shop model . The primary endpoint was the weight change analyzed by both completer and intention-to-treat analyses . RESULTS A total of 147 subjects [ 81 % ( NND 81 % ; ADD 82 % ) ] completed the intervention . A high dietary compliance was achieved , with significant differences in dietary intakes between groups . The mean ( ±SEM ) weight change was -4.7 ± 0.5 kg for the NND compared with -1.5 ± 0.5 kg for the ADD ( adjusted difference : -3.2 kg ; 95 % CI : -4.6 , -1.8 kg ; P < 0.001 ) for the completer analysis , and the difference was -3.0 kg ( 95 % CI : -4.0 , -2.1 kg ) for the intention-to-treat analysis . The NND produced greater reductions in systolic blood pressure ( adjusted difference : -5.1 mm Hg ; 95 % CI : -8.2 , -2.1 mm Hg ) and diastolic blood pressure ( adjusted difference : -3.2 mm Hg ; 95 % CI : -5.7 , -0.8 mm Hg ) than did the ADD . CONCLUSION An ad libitum NND produces weight loss and blood pressure reduction in central ly obese individuals . This trial was registered at www . clinical trials.gov as NCT01195610 OBJECTIVE To investigate whether glycemic and lipid control in patients with non-insulin-dependent diabetes ( NIDDM ) can be significantly improved using a low-fat , vegetarian ( vegan ) diet in the absence of recommendations regarding exercise or other lifestyle changes . METHODS Eleven subjects with NIDDM recruited from the Georgetown University Medical Center or the local community were r and omly assigned to a low-fat vegan diet ( seven subjects ) or a conventional low-fat diet ( four subjects ) . Two additional subjects assigned to the control group failed to complete the study . The diets were not design ed to be isocaloric . Fasting serum glucose , body weight , medication use , and blood pressure were assessed at baseline and biweekly thereafter for 12 weeks . Serum lipids , glycosylated hemoglobin , urinary albumin , and dietary macronutrients were assessed at baseline and 12 weeks . RESULTS Although the sample was intentionally small in accordance with the pilot study design , the 28 % mean reduction in fasting serum glucose of the experimental group , from 10.7 to 7.75 mmol/L ( 195 to 141 mg/dl ) , was significantly greater than the 12 % decrease , from 9.86 to 8.64 mmol/L ( 179 to 157 mg/dl ) , for the control group ( P < 0.05 ) . The mean weight loss was 7.2 kg in the experimental group , compared to 3 . 8 kg for the control group ( P < 0.005 ) . Of six experimental group subjects on oral hypoglycemic agents , medication use was discontinued in one and reduced in three . Insulin was reduced in both experimental group patients on insulin . No patient in the control group reduced medication use . Differences between the diet groups in the reductions of serum cholesterol and 24-h microalbuminuria did not reach statistical significance ; however , high-density lipoprotein concentration fell more sharply ( 0.20 mmol/L ) in the experimental group than in the control group ( 0.02 mmol/L ) ( P < 0.05 ) . CONCLUSION The use of a low-fat , vegetarian diet in patients with NIDDM was associated with significant reductions in fasting serum glucose concentration and body weight in the absence of recommendations for exercise . A larger study is needed for confirmation Evidence suggests that diet and exercise are associated with improved glucose tolerance for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . Seventy-six volunteer adult patients with NIDDM were each assigned to one of four programs : 1 ) diet , 2 ) exercise , 3 ) diet plus exercise , or 4 ) education ( control ) . Each program required ten weekly meetings . Detailed evaluations were completed prior to the program and after three , six , 12 , and 18 months . Evaluations included various psychosocial measures , measures of the quality of life , and fasting blood glucose , glycosylated hemoglobin , and relative weight determinations . Of the 76 original participants , 70 completed the 18-month follow-up study . At 18 months , the combination diet- and -exercise group had achieved the greatest reductions in glycosylated hemoglobin measures . In addition , this group showed significant improvements on a general quality of life measure . These improvements were largely uncorrelated with changes in weight . The authors conclude that the combination of dietary change and physical conditioning benefits NIDDM patients , and that the benefits may be independent of substantial weight loss Background In patients with chronic hepatitis C ( CHC ) , obesity is involved in the pathogenesis of insulin resistance , fatty liver disease and progression of fibrosis . The objective of this study was to compare a normoglucidic low-calorie diet ( NGLCD ) with a low-fat diet ( LFD ) among participants with CHC . Aim ed to measure the impact of dietary changes in reduction of insulin resistance , obesity but also in steatosis and fibrosis . Methods R and omized , controlled trial in three medical centers with assessment s at baseline , 6 months and 12 months . Participants were patients over 35 years with chronic hepatitis C ( n = 120 ) with BMI over 25 kg/m2 . We evaluated the effects of NGLCD vs. LFD in weight management and metabolic improvement . The primary endpoint was to measure the impact of dietary changes through nutritional intervention in reversibility of insulin resistance , obesity , steatosis , and fibrosis . We performed anthropometric measurements , fasting glucose profile , serum lipids , liver profile , blood count at baseline , 6 and 12 months . Steatosis was evaluated using ultrasonographic criteria . Liver fibrosis was non-invasively assessed . Results After 6 and 12 months of intervention , both groups had a significant decrease in caloric consumption . At 6 months , weight loss was greater in the NGLCD group ( −5.02 ± 3.43 kg vs. −4.1 ± 2.6 kg ; p = 0.002 ) compared to the LFD group . At 1-year , however , weight loss was similar in both groups ( −3.9 ± 3.3 kg vs. −3.1 ± 2.6 kg ; p = 0.139 ) . At 12 months , fasting plasma glucose , fasting plasma insulin , and HOMA-IR had significant improvements in both groups . With both diets aspartate aminotransferase ( AST ) , alanine aminotransferase ( ALT ) , gamma-glutamyl transpeptidase ( GGT ) decreased with significant differences ; also there were significant improvements in AST/ALT ratio , Forns fibrosis index . The two diets were associated with reduction of both the prevalence and the severity of steatosis ( all p < 0.001 ) . At 12 months , total cholesterol , HDL-cholesterol , triglycerides improved in both groups ( all p < 0.05 ) . Conclusions The present study establishes the benefits of low-calorie diet and low-fat diet in management of patients with hepatitis C regarding improvement of insulin resistance , steatosis and also fibrosis . Overweight or obese patients with CHC undergoing a lifestyle intervention ( specific dietary intervention and physical activity ) for 1-year had significant improvements in body weight , lipid and hepatic profile . Trial registration PNCI2 - Background : Type-2 diabetes ( T2D ) prevalence is rapidly increasing worldwide . Lifestyle factors , in particular obesity , diet , and physical activity play a significant role in the etiology of the disease . Of dietary patterns , particularly the Mediterranean diet has been studied , and generally a protective association has been identified . However , other regional diets are less explored . Objective : The aim of the present study was to investigate the association between adherence to a healthy Nordic food index and the risk of T2D . The index consists of six food items : fish , cabbage , rye bread , oatmeal , apples and pears , and root vegetables . Methods : Data was obtained from a prospect i ve cohort study of 57,053 Danish men and women aged 50–64 years , at baseline , of whom 7366 developed T2D ( median follow-up : 15.3 years ) . The Cox proportional hazards model was used to assess the association between the healthy Nordic food index and risk of T2D , adjusted for potential confounders . Results : Greater adherence to the  healthy Nordic food index was significantly associated with lower risk of T2D after adjusting for potential confounders . An index score of 5−6 points ( high adherence ) was associated with a statistically significantly 25 % lower T2D risk in women ( HR : 0.75 , 95%CI : 0.61–0.92 ) and 38 % in men ( HR : 0.62 ; 95%CI : 0.53–0.71 ) compared to those with an index score of 0 points ( poor adherence ) . Conclusion : Adherence to a healthy Nordic food index was found to be inversely associated with risk of T2D , suggesting that regional diets other than the Mediterranean may also be recommended for prevention of T2D Abstract Purpose The New Nordic Diet ( NND ) has induced weight loss in a 26-week controlled intervention . We aim to investigate whether high compliance and satisfaction can be maintained after the active intervention is discontinued thereby maintaining the health effects . Methods After 26 weeks of intervention with NND or Average Danish Diet ( ADD ) , 147 participants ( mean age 43 years and mean BMI 29.1 kg/m2 ) were followed for further 52 weeks . All participants were encouraged to follow NND but without further guidance . The study is registered with Clinical Trials.gov , study i d NCT01195610 . Results One hundred and ten participants ( 75 % ) completed the follow-up . Among participants previously r and omised to NND ( NND group ) , dietary compliance and satisfaction decreased from 4.3 to 3.0 and from 4.8 to 4.0 , respectively ( both p < 0.0001 ) ( 1–5 point scale ) . Among those originally r and omised to ADD ( ADD group ) , satisfaction with NND was significantly higher than with ADD during follow-up ( 3.3 vs. 2.5 , p = 0.026 ) . Weight losses during intervention of −6.2 kg and −3.0 kg were followed by regains of 4.6 kg ( SE 0.5 ) and 1.1 kg ( SE 0.7 ) for the NND group and ADD group , respectively [ adjusted difference ; mean ( 95 % CI ) : 1.8 kg ( 0.1–3.4 ) , p = 0.041 ] . Across diet groups , every 1 score higher in compliance with NND was associated with 0.90 kg less body weight regain ( p = 0.026 ) and those who increased physical activity regained 3.4 kg less compared to those who did not ( p < 0.0001 ) . Conclusions NND  provides higher satisfaction , and body weight regain is reduced with higher compliance with NND and increased physical activity OBJECTIVE The aim of this study was to assess the effectiveness of a new dietary education ( NDE ) program in reducing plasma glucose ( PG ) levels in Japanese male workers at high risk for type 2 diabetes through a r and omized controlled trial . RESEARCH DESIGN AND METHODS We r and omly assigned 173 high-risk men ( mean age , 55 years ) to either the NDE or the  control ( conventional dietary education )  group . Each subject in the NDE group received two individualized interventions especially aim ed at reducing total energy intake at dinner by modifying dietary intake . The control group received conventional group counseling . An " overintake/underintake fraction " for total energy intake was used to measure the status of dietary intake . Our hypothesis was that the NDE group would have a 10 % decrease in 2-h PG 1 year after the start of the education . Outcome measures were compared with ANCOVA by adjusting for baseline values . RESULTS The NDE group had a significantly lower total energy intake at dinner and daily than the control group . The adjusted differences in changes from baseline in the absolute value of the ' overintake/underintake fraction ' were -15.3 % ( 95 % CI -24.6 to -6.0 % , P = 0.002 ) for dinner and -6.0 % ( -9.8 to -2.2 % , P = 0.002 ) for daily [ corrected ] . The NDE group had a decreased 2-h PG after 1 year , whereas that value was increased in the control group . The adjusted difference in the percent change of 2-h PG was significant ( -15.2 % , -22.0 to -8.4 % , P < 0.001 ) . CONCLUSIONS The NDE was shown to reduce glucose levels in high-risk subjects for type 2 diabetes A st and ard management protocol for newly diagnosed type 2 diabetes is a period of observation with diet therapy alone [ 1 , 2 ] . This strategy controls symptoms effectively in most patients , at least in the short term , by reducing glycemia and initiating weight loss where appropriate . It also stresses the importance of diet in diabetes management . However , if the fasting plasma glucose level continues to increase after diet therapy is started , a decision must be made to continue with diet alone or to start intensive therapy with oral hypoglycemic drugs or insulin . We have reported on the efficacy of these therapeutic options in the main r and omization group of the United Kingdom Prospect i ve Diabetes Study ( UKPS ) [ 3 , 4 ] . Here , we report the response to treatment with oral hypoglycemic drugs or insulin in a subgroup of patients recruited to the UKPS who continued to have marked hyperglycemia or hyperglycemic symptoms during the initial 3 months of diet therapy and in whom continued diet therapy alone was not an option . We sought to determine whether clinical or biochemical characteristics at diagnosis helped to define this subgroup of patients , whom we called the primary diet failure group , and the extent to which the different intensive therapies maintained control of blood glucose levels over 6 years of follow-up . We also compared the efficacy of the therapies in the primary diet failure group with that in the main r and omization group . Methods Patients In the parent study , we enrolled 4075 patients aged 25 to 65 years with newly diagnosed type 2 diabetes ( fasting plasma glucose level > 6 mmol/L on two occasions ) from 15 centers between 1977 and 1991 . Patients were excluded if they had ketonuria ( ketone concentration > 3 mmol/L ) ( 2 % of referrals ) , a history of myocardial infa rct ion in the previous year , or current angina or heart failure ; had had more than one major vascular episode ; had a serum creatinine level greater than 175 mol/L , severe retinopathy requiring photocoagulation , malignant hypertension , an uncorrected endocrine abnormality , or severe intercurrent illness likely to limit life expectancy ; or required extensive systemic therapy [ 3 ] . The parent study was approved by the institutional review board of each hospital and was conducted in accord with the Declaration of Helsinki as amended in Tokyo ( 1975 ) , Venice ( 1983 ) , and Hong Kong ( 1989 ) . Initial Diet Therapy and R and omization Initially , patients were seen monthly and prescribed a diet consisting of about 50 % carbohydrates , low saturated fat , and moderately high fiber , with reduced total calorie content if patients were obese ( > 120 % of ideal body weight ) . During this period , we identified 560 patients ( 13.7 % ) who had fasting plasma glucose levels greater than 15 mmol/L or persistent symptoms of hyperglycemia .  These 560 patients ( primary diet failure group ) were r and omly allocated to intensive treatment after we stratified for obesity [ 4 ] . Of the nonobese patients , 56 % received sulfonylurea ( chlorpropamide or glyburide ) and 44 % received insulin . Of the obese patients , 42 % received sulfonylurea , 32 % received insulin , and 26 % received metformin ( Figure 1 ) . Figure 1 . Flow chart showing patients who were entered into the primary diet failure group . At 3 months , 2769 of 4075 patients continued to receive diet therapy alone and were asymptomatic with fasting plasma glucose levels of 6 to 15 mmol/L. These 2769 patients formed the main r and omization group of the parent study and were allocated to the same intensive therapies as the primary diet failure group and to a group that was allocated diet therapy alone .  Seven hundred forty-six patients had fasting plasma glucose levels less than 6 mmol/L after 3 months of diet therapy ( diet satisfactory )  and were followed up . We compared patients in the primary diet failure group with those in the main r and omization group who received the same intensive therapy allocation . Measurements and Follow-up Sulfonylurea doses were adjusted with the aim of obtaining a fasting plasma glucose level less than 6.0 mmol/L without triggering episodes of hypoglycemia . If fasting plasma glucose levels were 15.0 mmol/L or more at two consecutive clinic visits or if symptoms of hyperglycemia developed while patients received the maximum sulfonylurea dosage ( chlorpropamide , 500 mg/d ; glyburide , 20 mg/d ) , metformin was added to the regimen . Glyburide was added if patients met these criteria while receiving the maximum metformin dosage ( 2550 mg/d ) . Patients who met these criteria while receiving both sulfonylurea and metformin were switched to insulin . Patients who were r and omized or switched to insulin received ultralente insulin ( initially , beef Ultratard MC ; subsequently , human Ultratard HM , Novo Nordisk , Pease Pottage , United Kingdom ) [ 5 ] . These patients monitored their blood glucose levels at home if they required more than 14 U of ultralente insulin daily . If blood glucose levels before meals or at bedtime were greater than 7.0 mmol/L , additional soluble insulin , two or three times daily , or twice-daily mixtures of medium-acting and short-acting insulins were advised . We defined monotherapy as allocated therapy with sulfonylurea , metformin , or ultralente insulin alone . At each 3-month visit , all patients were asked about hypoglycemic symptoms . The most severe hypoglycemic episode for each period was recorded ; the clinician grade d the episode as minor if the patient could treat the symptoms unaided or major if third-party help or medical intervention was necessary . We calculated the mean annual rates for major and all hypoglycemic episodes . The central laboratory monitored fasting plasma glucose levels at individual clinics by using a monthly quality assurance scheme in which a coefficient of variation of less than 4 % was maintained . In the central laboratory , glycosylated hemoglobin ( hemoglobin A1c ) was assayed by using high-pressure liquid chromatography ( normal range , 0.045 to 0.062 ) , and plasma insulin was assayed by using radioimmunoassay with 100 % cross-reactivity to proinsulin [ 6 ] . Levels of high-density lipoprotein cholesterol and total cholesterol were measured directly by precipitation methods [ 7 ] . The Homeostasis Model Assessment [ 8 - 10 ] , a structural model of glucose-insulin interactions , was used to estimate the percentages of -cell function and insulin sensitivity that would induce the measured fasting levels of insulin and glucose of each participant . Percentages of -cell function and insulin sensitivity were expressed in relation to a reference group of 40 normoglycemic persons ( age , 18 to 25 years ; body mass index , 18 to 25 kg/m2 ) and were assessed in all patients at r and omization . They were also assessed in patients who continued to receive sulfonylurea or metformin therapy at 1 year . Diabetic retinopathy was assessed by a modified Wisconsin grading of color retinal photography of four horizontal , 30-degree fields per eye [ 3 , 11 ] . The presence of retinopathy was defined as grade 20 - 20 or worse ( that is , microaneurysm in both eyes or more severe retinopathy in one eye ) . Statistical Analysis Statistical analyses were done by using SAS software [ 12 ] according to allocated therapy on an intention-to-treat basis , except where stated . For description of the groups , the mean SD , the geometric mean ( 1-SD interval ) , or the median ( interquartile range ) is given . For differences across time , data are expressed as the mean with a 95 % CI . Percentages are quoted with 95 % CIs except where the actual numbers of patients are given . We used the Mann-Whitney U test , t-test , or analysis of variance with paired comparisons using a Bonferroni correction to compare groups , and we used chi-square tests to compare proportions . Repeated- measures analysis of variance was used to compare data between groups across time . Adjustment for baseline values used analysis of covariance . We calculated estimates of survival functions for time to requirement of additional therapy by using the product-limit ( Kaplan-Meier ) method . For this analysis , patients were placed in three groups according to tertiles of the distributions of age or body mass index at r and omization . For all analyses , a P value less than 0.05 was considered significant . Annual data for body weight and fasting plasma glucose level were calculated as the median of three consecutive visits for each patient ( the annual visit and the preceding and subsequent 3-month visit ) . Hemoglobin A1c concentrations and plasma levels of insulin and lipids were assessed annually . Role of Industry Sponsors Our study was supported in part by pharmaceutical companies , including Novo Nordisk ; Bayer ; Bristol-Myers Squibb ; Hoechst ; Lilly ; Lipha ; and Farmitalia Carlo Erba . Additional assistance was granted by Boehringer Mannheim , Becton Dickinson , Owen Mumford , Securicor , Kodak , and Cortecs Diagnostics . None of the funding sources had a role in the collection , analysis , or interpretation of the data or in the decision to publish this report . Results We present 6-year follow-up data for 458 of 560 patients in the primary diet failure group and 1620 of 2769 patients in the main r and omization group . The remaining patients were lost to follow-up ( main r and omization group , 96 [ 3 % ] ; primary diet failure group , 10 [ 5 % ] ) , had died ( main r and omization group , 144 [ 5 % ] ; primary diet failure group , 11 [ 5 % ] ) , or had not reached the 6-year time point ( main r and omization group , 909 [ 33 % ] ; primary diet failure group , 81 [ 36 % ] ) . At baseline , patients who were followed did not differ from those who were not . The median time spent receiving diet therapy alone from recruitment to r and omization was 42 days ( 95 % CI , 22 to 63 days ) in the primary diet failure group and 103 days ( CI , 91 to 119 days ) in the main r and omization group ( P < 0.001 ) . Clinical and Biochemical Characteristics at Baseline Patients in the primary diet failure group were significantly younger and less obese than patients in the main r and omization group ( Table 1 ) .
This dietary pattern did not significantly affect 2-h post-pr and ial blood glucose and Matsuda index .
Conclusions Adherence to the ND might improve serum insulin and HOMA-IR levels ; however , this effect was not confirmed for other markers of blood glucose control .
Aims Investigations on the possible effect of the Nordic diet ( ND ) on the glycemic control and the risk of diabetes have led to inconsistent results .
The present study tried to determine the effect of the ND on the markers of blood glucose control using a systematic review and meta- analysis of r and omized controlled clinical trials ( RCTs ) .