Reproducibility and construct validity of a food frequency questionnaire for assessing dietary intake in rural and urban Asian Indian adults.

BACKGROUND AND OBJECTIVES: To evaluate the reproducibility and construct validity of the Madras Diabetes Research Foundation FFQ (MDRF-FFQ) with biomarkers for its use in epidemiological settings in India. METHODS AND STUDY DESIGN: The MDRF-FFQ was administered to 500 participants representing rural and urban areas of 10 Indian states, twice at an interval of 12 months. Reproducibility was assessed using intra cluster correlation coefficients (ICC). Construct validity of carbohydrate and fat intake was assessed using baseline serum lipids by regression analysis. RESULTS: Reproducibility as measured by ICC was 0.50-0.77 for saturated fatty acids (SFA) and energy in urban and 0.61-0.72 for protein and SFA in rural areas. The ICC for food groups was 0.53-0.77 for whole grains, fruits and vegetables in urban and 0.50-0.89 for animal foods and whole grains in rural areas. After adjusting for potential confounders, carbohydrate intake was positively associated with serum triglycerides (TG) (ß [SE]: +2.3 [0.72] mg/dL; p=0.002) and inversely with high density lipoprotein cholesterol (HDL) (ß [SE]:-0.48 [0.12], p<0.001), while dietary fat and SFA (% Energy) were positively associated with HDL, low density lipoprotein (LDL) and total cholesterol and inversely with TG. CONCLUSIONS: The MDRF-FFQ can be considered as a reliable and valid tool to measure the long-term dietary exposure in respect of macronutrient intakes in Indian populations despite diverse dietary practices.

A Pilot Study Evaluating the Effects of Diabetes Specific Nutrition Supplement and Lifestyle Intervention on Glycemic Control in Overweight and Obese Asian Indian Adults with Type 2 Diabetes Mellitus.

BACKGROUND AND OBJECTIVES: Medical nutrition therapy plays a crucial role achievement of optimal glycemic control in individuals with diabetes. This study aims to evaluate the effects of diabetes specific nutrition supplement (DSNS) along with lifestyle intervention in overweight and obese adults with Type 2 Diabetes Mellitus (T2DM). METHODS: A total of 120 overweight or obese individuals aged 30 - 65 years with T2DM, were randomly allocated to intervention (IG, n=60) and control (CG, n=60) groups in this 12-week study. All participants received dietary counselling with diet chart of 1400 kcal/day and recommendations for physical activity. DSNS was included in the dietary regimen adjusted within the daily calorie recommendations for intervention group. All participants were followed up monthly for anthropometric, biochemical and clinical assessments. Continuous glucose monitoring was performed during the initial 2 weeks and last 2 weeks of the study in a sub- sample using Flash Glucose Monitoring device to study glycemic excursions. Data was analyzed for the differences between intervention vs. control group using linear models. RESULTS: Compared to the control group, the intervention group showed significant reduction in glycosylated haemoglobin (IG: -0.95% vs. CG: -0.48%; p=0.020) and fasting blood glucose (IG: -18.47 mg/dL vs. CG: 1.34mg/dL; p=0.03) as well as a greater reduction in postprandial plasma glucose (IG: -29.77mg/dL vs. CG: -2.64mg/dL; p=0.053). There was also a significant reduction from baseline in incremental Area under the Curve (iAUC) (p=0.01) in the intervention group (Δ -22 mg) compared to the control group (Δ -7.9 mg) with a corresponding reduction in the Mean Amplitude of Glycemic Excursion (MAGE) (P=0.04). There was no difference between groups in body weight, waist circumference, blood pressure, and lipid profile. None of the subjects in the study reported serious adverse events. CONCLUSION: This pilot study showed that a diabetes specific nutritional supplement was useful in improving glycemic control and reducing glycemic response in overweight and obese Asian Indian adults with T2DM.

Glycemic index of a nutritional supplement designed for people with chronic kidney disease.

The study was carried out to measure the glycemic index (GI) of an oral food supplement for people with CKD as well as on patients on maintenance dialysis. The study was conducted as per international protocols for testing GI, was approved by the local institutional ethics committee, and was registered with the Clinical Trial Registry of India (CTRI). This was a crossover randomized controlled study which enrolled 15 participants between the ages of 18 and 45 years. The participants were randomly allotted to one group that consumed either the reference food (27.5 g of glucose monohydrate) or 118 g of the nutritional supplement which contained 25 g of available carbohydrates. Fasting capillary blood samples as well as blood samples at different time intervals as per the GI protocol, after consumption of either the supplement or the reference food were taken from the participants. Each testing day was separated by a 3-day washout period. GI was calculated from the incremental area under the blood glucose response elicited by the nutritional supplement as a percentage of the response after the consumption of 25 g of glucose (27.5 g of glucose monohydrate) by the same participant using a standard formula. The GI of the nutritional supplement was calculated to be 10.3 ± 2.0 which is considered to be low as per international GI testing standards. The product was created to supplement the diet of people with CKD at different stages and to help prevent the progression from CKD to ESRD as well as the risk for CVD. This product was found to have a low GI which is desirable for people with CKD as well as diabetics in general who are at risk for developing CKD.

Effect of almond consumption on insulin sensitivity and serum lipids among Asian Indian adults with overweight and obesity- A randomized controlled trial.

Background: Asian Indians have an increased susceptibility to type 2 diabetes and premature coronary artery disease. Nuts, like almonds, are rich in unsaturated fat and micronutrients with known health benefits. Objectives: This study aimed to assess the efficacy of almonds for reduction of insulin resistance and improving lipid profile in overweight Asian Indian adults. Methods: This parallel-arm, randomized, controlled trial was conducted in Chennai, India on 400 participants aged 25-65 years with a body mass index ≥ 23 kg/m2. The intervention group received 43 g of almonds/day for 12 weeks, while the control group was advised to consume a customary diet but to avoid nuts. Anthropometric, clinical, and dietary data were assessed at periodic intervals. Glucose tolerance, serum insulin, glycated hemoglobin, C-peptide and lipid profile were assessed at baseline and end of the study. Insulin resistance (homeostasis assessment model-HOMA IR) and oral insulin disposition index (DIo) were calculated. Results: A total of 352 participants completed the study. Significant improvement was seen in DIo [mean (95% CI) = + 0.7 mmol/L (0.1, 1.3); p = 0.03], HOMA IR (-0.4 (-0.7, -0.04; p = 0.03) and total cholesterol (-5.4 mg/dl (-10.2, -0.6); p = 0.03) in the intervention group compared to the control group. Incremental area under the curve (IAUC) and mean amplitude of glycemic excursion (MAGE) assessed using continuous glucose monitoring systems were also significantly lower in the intervention group. Dietary 24-h recalls showed a higher significant reduction in carbohydrate and increase in mono unsaturated fatty acid (MUFA) and polyunsaturated fatty acids (PUFA) intake in the intervention group compared to the control group. Conclusion: Daily consumption of almonds increased the intake of MUFA with decrease in carbohydrate calories and decreases insulin resistance, improves insulin sensitivity and lowers serum cholesterol in Asian Indians with overweight/obesity. These effects in the long run could aid in reducing the risk of diabetes and other cardiometabolic disease.