Premeal almond load decreases postprandial glycaemia, adiposity and reversed prediabetes to normoglycemia: A randomized controlled trial.

BACKGROUND: Asian Indians show rapid conversion from prediabetes to type 2 diabetes (T2D). Novel dietary strategies are needed to arrest this progression, by targeting postprandial hyperglycaemia (PPHG). DESIGN: We conducted a free-living randomized controlled open-label parallel arm study to evaluate the effect of a premeal load of almonds (20 g) 30 min before major meals on anthropometric, glycaemic, and metabolic parameters over 3 months. Sixty-six participants with prediabetes in the age range of 18-60 yrs were recruited. The study was registered at clinicaltrials.gov (registration no. NCT04769726). RESULTS: Thirty participants in each arm completed the study. As per 'intention-to-treat' analysis, overall additional mean reductions were statistically significant for body weight, BMI, waist circumference (WC), subscapular and suprailiac skinfolds, and improved handgrip strength (Kg) (p < 0·001 for all) in the treatment arm vs. the control arm (after multiple adjustments). In the blood parameters, the additional mean reduction in the treatment arm vs. control arm was statistically significant for fasting and post-75 g oral glucose-load blood glucose, postprandial insulin, HOMA-IR, HbA1c, proinsulin, total cholesterol, and very low-density lipoprotein cholesterol (p < 0·001 for all). Most importantly, we observed a reversal to normoglycemic state (fasting blood glucose and 2 h post-OGTT glucose levels) in 23.3% (7 out of 30) of participants in the treatment arm which is comparable to that seen with Acarbose treatment (25%). CONCLUSION: Incorporation of 20 g of almonds, 30 min before each major meal leads to significant improvement in body weight, WC, glycemia (particularly PPHG), and insulin resistance and shows potential for reversal of prediabetes to normal glucose regulation over 3 months.

Beneficial effects of premeal almond load on glucose profile on oral glucose tolerance and continuous glucose monitoring: randomized crossover trials in Asian Indians with prediabetes.

BACKGROUND: Rapid conversion from prediabetes to diabetes and frequent postprandial hyperglycemia (PPHG) is seen in Asian Indians. These should be the target of dietary strategies. OBJECTIVES: We hypothesized that dietary intervention of preloading major meals with almonds in participants with prediabetes will decrease overall glycemia and PPHG. DESIGN: The study included two phases: (1) an oral glucose tolerance test (OGTT)-based crossover randomized control study, the effect of a single premeal almond load (20 g) given before OGTT was evaluated (n = 60, 30 each period). (2) The continuous glucose monitoring system (CGMS)-based study for 3 days including premeal almond load before three major meals was a free-living, open-labeled, crossover randomized control trial, where control and premeal almond load diets were compared for glycaemic control (n = 60, 30 in each period). The study was registered at clinicaltrials.gov (registration no. NCT04769726). RESULTS: In the OGTT-based study phase, the overall AUC for blood glucose, serum insulin, C-peptide, and plasma glucagon post-75 g oral glucose load was significantly lower for treatment vs. control diet (p < 0.001). Specifically, with the former diet, PPHG was significantly lower (18.05% in AUC on OGTT, 24.8% at 1-h, 28.9% at 2-h post OGTT, and 10.07% during CGMS). The CGMS data showed that premeal almond load significantly improved 24-glucose variability; SD of mean glucose concentration and mean of daily differences. Daily glycaemic control improved significantly as per the following: mean 24-h blood glucose concentration (M), time spent above 7.8 mmol/L of blood glucose, together with the corresponding AUC values. Premeal almond load significantly decreased following: overall hyperglycemia (glucose AUC), PPHG, peak 24-h glycaemia, and minimum glucose level during night. CONCLUSION: Incorporation of 20 g of almonds, 30 min before each major meal led to a significant decrease in PPHG (as revealed in OGTT-based study phase) and also improved insulin, C-peptide, glucagon levels, and improved glucose variability and glycemic parameters on CGMS in participants with prediabetes. CLINICAL TRIAL REGISTRY: The study was registered at clinicaltrials.gov (registration no. NCT04769726).

The influence of polymorphisms of fat mass and obesity (FTO, rs9939609) and vitamin D receptor (VDR, BsmI, TaqI, ApaI, FokI) genes on weight loss by diet and exercise interventions in non-diabetic overweight/obese Asian Indians in North India.

OBJECTIVE: The aim of the present study was to evaluate polymorphisms of fat mass and obesity (FTO; rs9939609) and vitamin D receptor (VDR, FokI (rs2228570), BsmI (rs1544410), ApaI (rs7975232), and TaqI (rs731236)] genes on weight loss after lifestyle interventions in Asian Indians. METHODS: In this 6-month pre-post intervention trial, 110 overweight/obese men and women underwent diet and exercise interventions for 180 days resulting in reduction in body weight, (5.1 kg, p < 0.001), waist circumference, and skinfolds. RESULTS: Association of the following genotypes was seen in those with ≥5% weight loss: TT of FTO polymorphism; 35 (81.4%) [OR (95% CI) AT, 2.5 (0.6, 10.9); TT, 6.9 (1.6, 28.2); with reference to AA], tt of VDR TaqI polymorphism, 12 (92.3%) [OR (95% CI); tt, 32.2 (2.4, 436.4); TT, 0.5 (0.08, 3.1); all with reference to Tt], bb of VDR BsmI polymorphism; 27 (65.8%) [OR (95% CI) Bb, 0.2 (0.04, 0.9); bb, 10.6 (0.9, 120.3); all with reference to BB] after adjusting for other genotypes. Further, analysis of combined influence of genotypes conferring maximum weight loss showed that the following had high odds of ≥5% weight loss: (1) TT of FTO gene in combination with BB/Bb of VDR BsmI and TT/Tt of VDR TaqI [OR (95% CI) 5.1 (1.5, 17.4)], (2) bb of BsmI and AA/AT of FTO and tt of TaqI [OR (95% CI) 3.2 (0.3, 31.7)], and (3) bb of BsmI plus TT of FTO and tt of TaqI. CONCLUSIONS: The above observations suggest a significant and independent role of the genotypes of FTO and VDR in influencing weight loss after lifestyle intervention in Asian Indians.

Does preoperative CA-125 cutoff value and percent reduction in CA-125 levels correlate with surgical and survival outcome after neoadjuvant chemotherapy in patients with advanced-stage ovarian cancer? - Our experience from a tertiary cancer institute.

AIM: The aim of the study is to evaluate percent fall in CA-125 levels after neoadjuvant chemotherapy (NAC) and preoperative CA-125 value to predict surgical and survival outcomes in women with advanced-stage epithelial ovarian cancer (EOC). METHODS: A retrospective review of 406 women receiving NAC for advanced-stage EOC from January 2012 to July 2015 was conducted. Data were collected for demography, radiographic profile, CA-125 levels before and after NAC, chemotherapy, and surgicopathological information. Percent fall in CA-125 was categorized into two groups: <95% (R < 95) and >95% (R > 95) fall from prechemotherapy to preoperative levels. Similarly, women were also categorized using preoperative CA-125 levels of <100 and >100 U/ml. A subset of women from January 2012 to December 2013 was followed to June 2015 for evidence of any recurrence to determine survival outcomes. RESULTS: About 56% women had R > 95 and 44% had R < 95. As compared to R < 95, R > 95 group was more likely to have complete cytoreduction (P = 0.00). Furthermore, women with R > 95 had significant better progression-free survival (PFS) as compared to women with R < 95 (P = 0.009) but no difference in overall survival (OS) (P = 0.28). Women with preoperative CA-125 <100 had significant higher number of complete cytoreduction (55% vs. 40%; P = 0.00) and were associated with both PFS (P = 0.007) and OS benefit (P = 0.02). CONCLUSION: Our data showed that >95% fall in CA-125 and an absolute preoperative CA-125 value of <100 U/ml is associated with better surgical and survival outcome in women with advanced EOC. These data are important in patient counseling and treatment planning.

Effect of high-protein meal replacement on weight and cardiometabolic profile in overweight/obese Asian Indians in North India.

The aim of the present study was to evaluate the impact of a high-protein meal replacement (HPMR) on weight and metabolic, lipid and inflammatory parameters in overweight/obese Asian Indians. In this 12-week open-label, parallel-arm randomised controlled trial, 122 overweight/obese men and women were administered either a HPMR or a control diet after 2 weeks of diet and exercise run-in. Body weight, waist circumference (WC), percentage body fat (%BF), fasting blood glucose, post-oral glucose tolerance test (post-OGTT) blood glucose, fasting and post-OGTT serum insulin, lipid profile, high-sensitivity C-reactive protein (hs-CRP), kidney function and hepatic aminotransferases were assessed before and after the intervention. Additional improvement in mean values for the following parameters in the HPMR group compared with the control group was observed: body weight, 4·9 % (95 % CI 3·8, 6·1; P<0·001); WC, 3·8 % (95 % CI 2·5, 5·1; P<0·001); %BF, 6·3 % (95 % CI 4·3, 8·2; P<0·001); systolic blood pressure, 2·8 % (95 % CI 0·4, 5·1; P=0·002); diastolic blood pressure, 3·5 % (95 % CI 0·7, 6·3; P= 0·01); post-OGTT blood glucose, 7·3 % (95 % CI 1·4, 13·1; P=0·02); total cholesterol, 2·5 % (95 % CI 1·6, 3·5; P<0·001); LDL-cholesterol, 7·3 % (95 % CI 1·7, 12·9; P<0·01); alanine aminotransferase, 22·0 % (95 % CI 2·1, 42; P=0·03) and aspartate aminotransferase, 15·2 % (95 % CI 0·9, 29·5; P=0·04). The absolute reduction in BMI was 0·9 units in the intervention arm compared with the control arm (-0·9 %, 95 % CI -1·4, -0·5; P<0·001) and in serum TAG was 11·9 mg/dl (-11·9 mg/dl, 95 % CI -21·1, -2·7; P<0·01). The reduction in fasting serum insulin in the intervention v. the control arm was 3·8 v. 0 % (P=0·002); post-OGTT serum insulin was 50·3 v. 77·3 mU/l (P=0·005); and hs-CRP, 16·7 % v. 0 % (P=0·002). These findings show that intervention with HPMR may lead to significant weight loss and improvement in obesity measures, metabolic, lipid and inflammatory parameters and hepatic transaminases in overweight/obese Asian Indians.