Effect of Isocaloric, Time-Restricted Eating on Body Weight in Adults With Obesity : A Randomized Controlled Trial.

BACKGROUND: Time-restricted eating (TRE) lowers body weight in many studies. Whether TRE induces weight loss independent of reductions in calorie intake, as seen in rodent studies, is unknown. OBJECTIVE: To determine the effect of TRE versus a usual eating pattern (UEP) on body weight in the setting of stable caloric intake. DESIGN: Randomized, isocaloric feeding study. (ClinicalTrials.gov: NCT03527368). SETTING: Clinical research unit. PARTICIPANTS: Adults with obesity and prediabetes or diet-controlled diabetes. INTERVENTION: Participants were randomly assigned 1:1 to TRE (10-hour eating window, 80% of calories before 1 p.m.) or UEP (≤16-hour window, ≥50% of calories after 5 p.m.) for 12 weeks. Both groups had the same nutrient content and were isocaloric with total calories determined at baseline. MEASUREMENTS: Primary outcome was change in body weight at 12 weeks. Secondary outcomes were fasting glucose, homeostatic model assessment for insulin resistance (HOMA-IR), glucose area under the curve by oral glucose tolerance test, and glycated albumin. We used linear mixed models to evaluate the effect of interventions on outcomes. RESULTS: All 41 randomly assigned participants (mean age, 59 years; 93% women; 93% Black race; mean BMI, 36 kg/m2) completed the intervention. Baseline weight was 95.6 kg (95% CI, 89.6 to 101.6 kg) in the TRE group and 103.7 kg (CI, 95.3 to 112.0 kg) in the UEP group. At 12 weeks, weight decreased by 2.3 kg (CI, 1.0 to 3.5 kg) in the TRE group and by 2.6 kg (CI, 1.5 to 3.7 kg) in the UEP group (average difference TRE vs. UEP, 0.3 kg [CI, -1.2 to 1.9 kg]). Change in glycemic measures did not differ between groups. LIMITATION: Small, single-site study; baseline differences in weight by group. CONCLUSION: In the setting of isocaloric eating, TRE did not decrease weight or improve glucose homeostasis relative to a UEP, suggesting that any effects of TRE on weight in prior studies may be due to reductions in caloric intake. PRIMARY FUNDING SOURCE: American Heart Association.

Ingesting probiotic yogurt containing Lactiplantibacillus plantarum OLL2712 improves glycaemic control in adults with prediabetes in a randomized, double-blind, placebo-controlled trial.

AIM: The ingestion of Lactiplantibacillus plantarum OLL2712 (OLL2712) cells has been shown to improve glucose metabolism by suppressing chronic inflammation in murine models and clinical studies. This study aimed to clarify the effect of OLL2712 on glycaemic control in healthy adults with prediabetes. MATERIALS AND METHODS: The study was a randomized, double-blind, placebo-controlled, parallel-group design. Adult participants with prediabetes [n = 148, glycated haemoglobin (HbA1c) range: 5.6%-6.4%, age range: 20-64 years] were assigned randomly to placebo or OLL2712 groups (n = 74/group) and administered daily for 12 weeks either conventional yogurt or yogurt containing >5 × 109 heat-treated OLL2712 cells, respectively. In addition, the participants were followed for 8 weeks after the discontinuation of either yogurt. The primary outcome was the changes in HbA1c levels at weeks 12 and 16 by analysis of covariance. RESULTS: The levels of HbA1c and glycoalbumin decreased significantly in both groups at week 12 in comparison with those at week 0, but only in the OLL2712 group at week 16. HbA1c levels decreased significantly at weeks 12 and 16 in the OLL2712 group in comparison with the placebo group (p = .014 and p = .006, respectively). No significant inter- and intragroup differences in HbA1c levels were observed at week 20. CONCLUSIONS: The ingestion of OLL2712 prevents the deterioration of glycaemic control and maintains the HbA1c levels within the normal range in adults with prediabetes; yogurt probably exhibits similar effects, which may contribute to reducing the risk of developing type 2 diabetes.

Effects of vitamin D and/or calcium intervention on sleep quality in individuals with prediabetes: a post hoc analysis of a randomized controlled trial.

PURPOSE: The aim of this study was to evaluate the effects of vitamin D and/or calcium supplementation on sleep quality in individuals with prediabetes. METHODS: A 24-week randomized controlled trial (RCT) was conducted in a 212 Chinese population with prediabetes. Participants were randomly assigned to four groups: vitamin D + calcium group (1600 IU/day + 500 mg/day, n = 53), vitamin D group (1600 IU/day, n = 54), calcium group (500 mg/day, n = 51), and control group (placebo, n = 54). The Pittsburgh Sleep Quality Index (PSQI) was used as the primary outcome to assess sleep quality. Questionnaires and fasting blood samples were collected at baseline and post-intervention for demographic assessment and correlation index analysis. RESULTS: After a 24-week intervention, a significant difference was observed in serum 25(OH)D concentration among the four groups (P < 0.05), and the total PSQI score in vitamin D + calcium group was lower compared to the preintervention levels. Subgroup analyses revealed improved sleep quality with calcium supplementation (P < 0.05) for specific groups, including women, individuals with a low baseline 25(OH)D level (< 30 ng/mL), and individuals in menopause. Moreover, correlation analysis revealed a negative correlation between the extent of change in sleep efficiency scores before and after the calcium intervention and the degree of change in insulin efficiency scores (r = - 0.264, P = 0.007), as well as the magnitude of change in islet beta cell function (r = - 0.304, P = 0.002). CONCLUSIONS: The combined intervention of vitamin D and calcium, as well as calcium interventions alone, exhibits substantial potential for improving sleep quality in individuals with prediabetes. CLINICAL TRIAL REGISTRATION: The trial was registered in August 2019 as ChiCTR190002487.

A very-low-calorie diet (VLCD) intervention for the management of prediabetes and early Type 2 diabetes mellitus in a multi-ethnic cohort in Aotearoa New Zealand: The PROGRESS NZ feasibility study.

BACKGROUND AND OBJECTIVES: Very-low calorie diets (VLCD) achieve weight loss and remission of Type 2 diabetes (T2DM), but efficacy and acceptability in non-European populations is less clear. This feasibility study examines the impact of 10% weight loss through VLCD on metabolic and body composition outcomes in a multi-ethnic cohort of Aotearoa New Zealand (AoNZ) men with prediabetes/early T2DM, and VLCD tolerability/cultural acceptability. METHODS AND STUDY DESIGN: Participants followed a VLCD intervention (mean energy 3033kJ/day) until achievement of 10% weight loss. An oral glucose tolerance test (OGTT), hyperinsulinaemic isoglycaemic clamp with stable isotopes, hood calorimetry and dual-energy Xray absorptiometry (DXA) were undertaken before and after intervention. Qualitative data on VLCD tolerability/cultural acceptability were collected. RESULTS: Fifteen participants were enrolled; nine achieved 10% weight loss. In this group, mean HbA1c reduced by 4.8mmol/mol (2.4-7.1) and reverted to normoglycaemia in n=5/9; mean body weight reduced by 12.0 kg (11.0-13.1) and whole-body glucose disposal improved by 1.5 mg kgFFM-1 min-1 (0.7-2.2). Blood pressure and fasting triglycerides improved significantly. No changes in hepatic glu-cose metabolism were found. In all participants who attended completion testing, HbA1c reduced by 3.4mmol/mol (SD 3.5) and total weight by 9.0kg (SD 5.7). The intervention was highly tolerable/culturally acceptable however challenges with fulfilment of cultural obligations were described. CONCLUSIONS: Results support VLCD use in AoNZ however further work to investigate ethnic differences in physiological response to VLCDs and to optimise protocols for multi-ethnic populations are required.

Acute Nutritional Ketosis and Its Implications for Plasma Glucose and Glucoregulatory Peptides in Adults with Prediabetes: A Crossover Placebo-Controlled Randomized Trial.

BACKGROUND: The potential of a ketone monoester (ß-hydroxybutyrate; KEßHB) supplement to rapidly mimic a state of nutritional ketosis offers a new therapeutic possibility for diabetes prevention and management. While KEßHB supplementation has a glucose-lowering effect in adults with obesity, its impact on glucose control in other insulin-resistant states is unknown. OBJECTIVES: The primary objective was to investigate the effect of KEßHB-supplemented drink on plasma glucose in adults with prediabetes. The secondary objective was to determine its impact on plasma glucoregulatory peptides. METHODS: This randomized controlled trial [called CETUS (Cross-over randomizEd Trial of ß-hydroxybUtyrate in prediabeteS)] included 18 adults [67% men, mean age = 55 y, mean BMI (kg/m2) = 28.4] with prediabetes (glycated hemoglobin between 5.7% and 6.4% and/or fasting plasma glucose between 100 and 125 mg/dL). Participants were randomly assigned to receive KEßHB-supplemented and placebo drinks in a crossover sequence (washout period of 7-10 d between the drinks). Blood samples were collected from 0 to 150 min, at intervals of 30 min. Paired-samples t tests were used to investigate the change in the outcome variables [ß-hydroxybutyrate (ßHB), glucose, and glucoregulatory peptides] after both drinks. Repeated measures analyses were conducted to determine the change in concentrations of the prespecified outcomes over time. RESULTS: Blood ßHB concentrations increased to 3.5 mmol/L within 30 minutes after KEßHB supplementation. Plasma glucose AUC was significantly lower after KEßHB supplementation than after the placebo [mean difference (95% CI): -59 (-85.3, -32.3) mmol/L × min]. Compared with the placebo, KEßHB supplementation led to significantly greater AUCs for plasma insulin [0.237 (0.044, 0.429) nmol/L × min], C-peptide [0.259 (0.114, 0.403) nmol/L × min], and glucose-dependent insulinotropic peptide [0.243 (0.085, 0.401) nmol/L × min], with no significant differences in the AUCs for amylin, glucagon, and glucagon-like peptide 1. CONCLUSIONS: Ingestion of the KEßHB-supplemented drink acutely increased the blood ßHB concentrations and lowered the plasma glucose concentrations in adults with prediabetes. Further research is needed to investigate the dynamics of repeated ingestions of a KEßHB supplement by individuals with prediabetes, with a view to preventing new-onset diabetes. This trial was registered at www.clinicaltrials.gov as NCT03889210.

High protein diet leads to prediabetes remission and positive changes in incretins and cardiovascular risk factors.

BACKGROUND AND AIMS: High Protein diets may be associated with endocrine responses that favor improved metabolic outcomes. We studied the response to High Protein (HP) versus High Carbohydrate (HC) Diets in terms of incretin hormones GLP-1 and GIP, the hunger hormone ghrelin and BNP, which is associated with cardiac function. We hypothesized that HP diets induce more pronounced release of glucose lowering hormones, suppress hunger and improve cardiac function. METHODS AND RESULTS: 24 obese women and men with prediabetes were recruited and randomized to either a High Protein (HP) (n = 12) or High Carbohydrate (HC) (n = 12) diet for 6 months with all food provided. OGTT and MTT were performed and GLP-1, GIP, Ghrelin, BNP, insulin and glucose were measured at baseline and 6 months on the respective diets. Our studies showed that subjects on the HP diet had 100% remission of prediabetes compared to only 33% on the HC diet with similar weight loss. HP diet subjects had a greater increase in (1) OGTT GLP-1 AUC(p = 0.001) and MTT GLP-1 AUC(p = 0.001), (2) OGTT GIP AUC(p = 0.005) and MTT GIP AUC(p = 0.005), and a greater decrease in OGTT ghrelin AUC(p = 0.005) and MTT ghrelin AUC(p = 0.001) and BNP(p = 0.001) compared to the HC diet at 6 months. CONCLUSIONS: This study demonstrates that the HP diet increases GLP-1 and GIP which may be responsible in part for improved insulin sensitivity and ß cell function compared to the HC diet. HP ghrelin results demonstrate the HP diet can reduce hunger more effectively than the HC diet. BNP and other CVRF, metabolic parameters and oxidative stress are significantly improved compared to the HC diet. CLINICALTRIALS. GOV IDENTIFIER: NCT01642849.

Effects of Consuming Almonds on Insulin Sensitivity and Other Cardiometabolic Health Markers in Adults With Prediabetes.

Objective: This study was designed to assess the effects of replacing high-carbohydrate (CHO) foods with raw almonds on insulin sensitivity and cardiometabolic health markers in overweight or obese adults with prediabetes.Method: This randomized crossover study consisted of two 6-week dietary intervention periods, separated by a ≥ 4-week washout. Subjects incorporated 1.5 oz of raw almonds twice daily or isocaloric CHO-based foods into their diets, with instructions to maintain body weight. Dietary intakes as well as insulin sensitivity, CHO metabolism indices, lipoprotein lipids and particles, and inflammatory markers were assessed.Results: Thirty-three subjects (17 male, 16 female), mean age 48.3 ± 2.2 years and body mass index 30.5 ± 0.7 kg/m2, provided evaluable data. Compared to CHO, almonds resulted in significantly (p < 0.01) higher intakes of protein, fat (unsaturated fatty acids), fiber, and magnesium and significantly (p < 0.001) lower intakes of CHO and sugars. No differences were observed between diet conditions for changes from baseline in the insulin sensitivity index from a short intravenous glucose tolerance test or other indices of glucose homeostasis. No significant differences were observed in biomarkers of cardiovascular risk except that the CHO intervention led to a shift toward a higher concentration of cholesterol in small, dense low-density lipoprotein subfraction 3+4 (LDL3 + 4) particles (p = 0.024 vs almonds).Conclusions: Intake of 3.0 oz/d raw almonds, vs energy-matched CHO foods, improved the dietary nutrient profile, but did not significantly affect insulin sensitivity and most markers of cardiometabolic health in overweight and obese men and women with prediabetes.

Plasma and Urinary (Poly)phenolic Profiles after 4-Week Red Raspberry (Rubus idaeus L.) Intake with or without Fructo-Oligosaccharide Supplementation.

Red raspberries (RRB) are high in anthocyanin- and ellagitannin- type (poly)phenols. This study aimed to investigate the effect of 4-week RRB supplementation on (poly)phenolic metabolism in adults with prediabetes and insulin-resistance (PreDM-IR); and whether adding fructo-oligosaccharides (FOS), prebiotics, would augment the microbial metabolites of RRB (poly)phenols. In a randomized crossover clinical trial, subjects (n = 35: PreDM-IR, n = 25; healthy Reference group, n = 10) consumed 1 cup RRB (fresh weight equivalence) per day and RRB with 8 g FOS per day each for 4 weeks in random order separated by 4-week washout. Plasma and urinary (poly)phenolic metabolites were characterized after (0-24h) consuming a RRB-based test drink (2 cups RRB) at baseline/week 0 and again after 4-week supplementations. A total of 123 (poly)phenolic metabolites were quantified. After 4-week RRB supplementation, several metabolite groups were significantly increased (p < 0.05), including urolithins, phenyl-γ-valerolactones, and phenolic acids. Supplementing FOS with RRB for 4 weeks enhanced benzoic acid derivatives compared to the baseline (p < 0.05). Specific effects of supplementation by metabolic status indicated 4-week RRB supplementation significantly increased microbial metabolites that were lower in PreDM-IR group. Our results suggest alterations in the capacity of PreDM-IR group to metabolize and render bioavailable raspberry-derived (poly)phenols when consumed regularly.

Addressing Lifestyle Management During Visits Involving Patients with Prediabetes: NAMCS 2013-2015.

BACKGROUND: The gap between treatment guidelines and clinical practice in prediabetes management has been identified in previous studies. The knowledge related to addressing lifestyle change during office visits in clinical practice to manage prediabetes is limited. OBJECTIVE: To describe patterns of lifestyle management addressed during office-based visits involving patients with prediabetes and identify factors associated with addressing lifestyle management during physician office visits in the USA. DESIGN: Cross-sectional study PARTICIPANTS: US National Ambulatory Medical Care Survey (NAMCS) data from 2013 to 2015 were combined to identify office-based visits involving patients with prediabetes. MAIN MEASURES: The major outcome is lifestyle management including diet/nutrition, exercise, and/or weight reduction. Patient and physician characteristics were collected for analysis. The prevalence and patterns of addressing lifestyle management during visits were estimated and described. Multivariate logistic regression model identified significant factors associated with lifestyle management. The patient visit weight was applied to all analyses to achieve nationally representative estimates. KEY RESULTS: Among 4039 office-based visits involving patients with prediabetes between 2013 and 2015, 22.8% indicated lifestyle management was addressed during the visits. Diet/nutrition, exercise, and weight reduction accounted for 86.1%, 62.6%, and 34.1% of the visits with lifestyle management addressed, respectively. Lifestyle management was more likely to be addressed during the visits involving patients with hyperlipidemia (OR = 1.74, 95% CI 1.24-2.46) and obesity (OR = 4.03, 95% CI 2.91-5.56), seeing primary physicians (vs. other specialties, OR = 1.46, 95% CI 1.03-2.08), and living in the southern region (vs. northeast, OR = 1.96, 95% CI 1.20-3.19). CONCLUSIONS: The prevalence of addressing lifestyle management during office visits involving patients with prediabetes remained low in the USA. Patients' clinical characteristics, geographic region, and physician's specialty were associated with addressing lifestyle management during the visits.

Prevention of type 2 diabetes in prediabetic patients by using functional olive oil enriched in oleanolic acid: The PREDIABOLE study, a randomized controlled trial.

AIM: To assess whether the regular intake of an oleanolic acid (OA)-enriched olive oil is effective in the prevention of diabetes. METHODS: In the PREDIABOLE study, prediabetic individuals (impaired fasting glucose and impaired glucose tolerance) of both sexes (176 patients, aged 30-80 years) were randomized to receive 55 mL/day of OA-enriched olive oil (equivalent dose 30 mg OA/day) [intervention group (IG)] or the same oil not enriched [control group (CG)]. The main outcome was the incidence of new-onset type 2 diabetes in both groups. RESULTS: Forty-eight new diabetes cases occurred, 31 in the CG and 17 in the IG. The multivariate-adjusted hazard ratio was 0.45 (95% CI, 0.24-0.83) for the IG compared with the CG. Intervention-related adverse effects were not reported. CONCLUSIONS: The intake of OA-enriched olive oil reduces the risk of developing diabetes in prediabetic patients. The results of the PREDIABOLE study promote the use of OA in new functional foods and drugs for the prevention of diabetes in individuals at risk of developing it.

Making dietary changes following a diagnosis of prediabetes: a qualitative exploration of barriers and facilitators.

AIM: To explore the experiences of people recently diagnosed with prediabetes and overweight or obese in making dietary changes following a six-month primary care nurse-delivered dietary intervention pilot. METHODS: Semi-structured interviews were conducted with 20 participants, purposefully selected to ensure a mix of ethnicity, gender and glycaemic outcome. Thematic analysis of interview data was undertaken. RESULTS: Participants described feeling shocked when they received the diagnosis of prediabetes. Three core themes, each containing subthemes, emerged: (i) supportive factors - determination not to develop diabetes, clear information and manageable strategies, and supportive relationships; (ii) barriers - lack of family support, financial constraints, social expectations around food, and chronic health issues; and (iii) overcoming challenges - growing and sharing food, using frozen vegetables and planning. Challenges related to cultural expectations around providing and partaking of food were more evident for indigenous Maori participants. CONCLUSIONS: A diagnosis of prediabetes provides a window of opportunity for healthcare professionals to work with those diagnosed and their families to make healthful dietary changes. Dietary guidance is likely to be most effective when individuals' life circumstances are taken into account. Clear information and supportive relationships to facilitate lifestyle change are extremely important. (Clinical Trials Registry No; ANZCTR ACTRN1261500080656).

Men and women respond differently to rapid weight loss: Metabolic outcomes of a multi-centre intervention study after a low-energy diet in 2500 overweight, individuals with pre-diabetes (PREVIEW).

AIMS: The PREVIEW lifestyle intervention study (ClinicalTrials.gov Identifier: NCT01777893) is, to date, the largest, multinational study concerning prevention of type-2 diabetes. We hypothesized that the initial, fixed low-energy diet (LED) would induce different metabolic outcomes in men vs women. MATERIALS AND METHODS: All participants followed a LED (3.4 MJ/810 kcal/daily) for 8 weeks (Cambridge Weight Plan). Participants were recruited from 8 sites in Europe, Australia and New Zealand. Those eligible for inclusion were overweight (BMI ≥ 25 kg/m2 ) individuals with pre-diabetes according to ADA-criteria. Outcomes of interest included changes in insulin resistance, fat mass (FM), fat-free mass (FFM) and metabolic syndrome Z-score. RESULTS: In total, 2224 individuals (1504 women, 720 men) attended the baseline visit and 2020 (90.8%) completed the follow-up visit. Following the LED, weight loss was 16% greater in men than in women (11.8% vs 10.3%, respectively) but improvements in insulin resistance were similar. HOMA-IR decreased by 1.50 ± 0.15 in men and by 1.35 ± 0.15 in women (ns). After adjusting for differences in weight loss, men had larger reductions in metabolic syndrome Z-score, C-peptide, FM and heart rate, while women had larger reductions in HDL cholesterol, FFM, hip circumference and pulse pressure. Following the LED, 35% of participants of both genders had reverted to normo-glycaemia. CONCLUSIONS: An 8-week LED induced different effects in women than in men. These findings are clinically important and suggest gender-specific changes after weight loss. It is important to investigate whether the greater decreases in FFM, hip circumference and HDL cholesterol in women after rapid weight loss compromise weight loss maintenance and future cardiovascular health.

Replacing carbohydrate during a glucose challenge with the egg white portion or whole eggs protects against postprandial impairments in vascular endothelial function in prediabetic men by limiting increases in glycaemia and lipid peroxidation.

Eggs attenuate postprandial hyperglycaemia (PPH), which transiently impairs vascular endothelial function (VEF). We hypothesised that co-ingestion of a glucose challenge with egg-based meals would protect against glucose-induced impairments in VEF by attenuating PPH and oxidative stress. A randomised, cross-over study was conducted in prediabetic men (n 20) who ingested isoenegertic meals (1674 kJ (400 kcal)) containing 100 g glucose (GLU), or 75 g glucose with 1·5 whole eggs (EGG), seven egg whites (WHITE) or two egg yolks (YOLK). At 30 min intervals for 3 h, brachial artery flow-mediated dilation (FMD), plasma glucose, insulin, cholecystokinin (CCK), lipids (total, LDL- and HDL-cholesterol; TAG), F2-isoprostanes normalised to arachidonic acid (F2-IsoPs/AA), and methylglyoxal were assessed. In GLU, FMD decreased at 30-60 min and returned to baseline levels by 90 min. GLU-mediated decreases in FMD were attenuated at 30-60 min in EGG and WHITE. Compared with GLU, FMDAUC was higher in EGG and WHITE only. Relative to baseline, glucose increased at 30-120 min in GLU and YOLK but only at 30-90 min in EGG and WHITE. GlucoseAUC and insulinAUC were also lower in EGG and WHITE only. However, CCKAUC was higher in EGG and WHITE compared with GLU. Compared with GLU, F2-IsoPs/AAAUC was lower in EGG and WHITE but unaffected by YOLK. Postprandial lipids and methylglyoxal did not differ between treatments. Thus, replacing a portion of a glucose challenge with whole eggs or egg whites, but not yolks, limits postprandial impairments in VEF by attenuating increases in glycaemia and lipid peroxidation.

Diets with a low glycaemic load have favourable effects on prediabetes progression and regression: a prospective cohort study.

BACKGROUND: To date, no study assessing the associations among glycaemic index (GI), glycaemic load (GL) and progression to diabetes has focused specifically on prediabetes. Moreover, the available data on the association between these variables and regression to normal glucose regulation (NGR) are insufficient. Therefore, the present study aimed to evaluate the longitudinal associations among GI, GL and prediabetes outcomes. METHODS: This prospective study included 640 adults aged 40-79 years with prediabetes at baseline. Dietary data were assessed using a previously validated 3-day food record. The participants were divided into three groups according to GI and GL tertiles. Outcomes were defined based on annual oral glucose tolerance test results. RESULTS: During a median of 5 years of follow-up, 127 incident cases of diabetes and 249 incident cases of NGR were identified. Dietary GL was positively associated with the risk of developing diabetes and negatively associated with the likelihood of reaching NGR at least once. Comparing the highest and lowest tertiles of GL, the multivariable-adjusted hazard ratios (95% confidence intervals) were 1.85 (1.07-3.21) for progression and 0.65 (0.44-0.96) for regression. No association was observed between GI and prediabetes outcomes in the fully adjusted models. CONCLUSIONS: Among patients with prediabetes, high dietary GL was positively associated with diabetes risk. Furthermore, a low-GL diet contributed to an increased incidence of reaching NGR.

Outcomes and Economic Benefits of Penn State Extension's Dining With Diabetes Program.

INTRODUCTION: Many diabetes education programs address the problem of diabetes, but little attention is given to the economic impact of such programs. Our objective was to assess the effectiveness of a community-based education program in improving diabetes-related lifestyle behaviors and biomarkers and ascertain the economic benefits of the program for adults aged 18 years or older with type 2 diabetes, prediabetes, or no diagnosis of diabetes in Pennsylvania. METHODS: From October 2012 through June 2015, Pennsylvania State University Extension's Dining with Diabetes program collected data on 2,738 adults with type 2 diabetes or prediabetes and adult family members without diabetes. The program consisted of 4 weekly 2-hour classes and a follow-up class conducted 3 months after the fourth 2-hour class. In the initial class and the follow-up class, participants completed a lifestyle questionnaire and their hemoglobin A1c and blood pressure were measured. Economic benefit was calculated as the medical expenditure cost savings resulting from program participation. RESULTS: At 3-month follow-up, a significant number of participants had improved their lifestyle behaviors (diet and physical activity), had reductions in hemoglobin A1c and blood pressure, and improved their diabetes status. The Dining with Diabetes program had a 5-year benefit-cost ratio of 2.49 to 3.35. CONCLUSION: Participants who completed the Dining with Diabetes program had significant improvements in diabetes-related biomarkers and lifestyle behaviors. If the Dining with Diabetes program were extended to half of the 1.3 million people living with diabetes in Pennsylvania and if they had similar improvements, the 1-year benefit to the state would be approximately $195 million, assuming a conservative 15% decrease in direct medical costs.

Normo-Carbohydrate Nutrition: Results from a Pilot Study.

This study was a test of the feasibility of educating a convenience sample about normo-carbohydrate nutrition (NCN). From May 2015 and May 2016, 51 participants were enrolled in this intervention study about NCN. Participants were measured for chest, waist, abdomen, and hip circumferences, weight, and height at start and month 1, 2, and 3. After 1 month, there was a significant reduction in hip circumference, weight, and BMI with similar findings after 2 and 3 months. Significant reductions in chest, hips, and weight among participants after repeated measures provide hope for this promising nutritional strategy.

Impact of preloading either dairy or soy milk on postprandial glycemia, insulinemia and gastric emptying in healthy adults.

PURPOSE: Milk protein ingestion reduces post-meal glycemia when consumed either before or together with carbohydrate foods. The aim of this study was to compare the effects of dairy and soy milk consumed either before (preload) or together with (co-ingestion) a carbohydrate (bread), on postprandial blood glucose, insulin and gastric emptying in healthy participants. METHODS: Twelve healthy Chinese male participants were studied on five separate occasions using a randomized crossover design. White wheat bread consumed with water was used as a reference meal. Capillary and venous bloods were sampled pretest and 3.5 h post-test meal for glucose and insulin measurement. Gastric emptying was measured using real-time ultrasonography. RESULTS: Co-ingestion of dairy milk or soy milk with bread lowered postprandial blood glucose response and glycemic index. Co-ingesting soy milk with bread increased insulin response and insulinemic index significantly compared to co-ingestion of dairy milk and preload treatments. Preloads (30 min prior to bread) significantly lowered postprandial glycemia and insulinemia compared to co-ingestion. Gastric emptying was slower after co-ingesting dairy milk with bread than after reference meal. CONCLUSIONS: Preloading either soy milk or dairy milk results in greater reduction in glycemic response compared to co-ingestion alone. This dietary practice may have therapeutic advantage in communities consuming high GI diets. Optimal glucose control may have the potential for increasing the time of transition from prediabetes to type 2 diabetes in Asian communities. CLINICAL TRIAL REGISTRATION: This trial was registered at clinicaltrials.gov as NCT 02151188.

Effects of exercise training alone vs a combined exercise and nutritional lifestyle intervention on glucose homeostasis in prediabetic individuals: a randomised controlled trial.

AIMS/HYPOTHESIS: Although the Diabetes Prevention Program (DPP) established lifestyle changes (diet, exercise and weight loss) as the 'gold standard' preventive therapy for diabetes, the relative contribution of exercise alone to the overall utility of the combined diet and exercise effect of DPP is unknown; furthermore, the optimal intensity of exercise for preventing progression to diabetes remains very controversial. To establish clinical efficacy, we undertook a study (2009 to 2013) to determine: how much of the effect on measures of glucose homeostasis of a 6 month programme modelled after the first 6 months of the DPP is due to exercise alone; whether moderate- or vigorous-intensity exercise is better for improving glucose homeostasis; and to what extent amount of exercise is a contributor to improving glucose control. The primary outcome was improvement in fasting plasma glucose, with improvement in plasma glucose AUC response to an OGTT as the major secondary outcome. METHODS: The trial was a parallel clinical trial. Sedentary, non-smokers who were 45-75 year old adults (n = 237) with elevated fasting glucose (5.28-6.94 mmol/l) but without cardiovascular disease, uncontrolled hypertension, or diabetes, from the Durham area, were studied at Duke University. They were randomised into one of four 6 month interventions: (1) low amount (42 kJ kg body weight(-1) week(-1) [KKW])/moderate intensity: equivalent of expending 42 KKW (e.g. walking ∼16 km [8.6 miles] per week) with moderate-intensity (50% [Formula: see text]) exercise; (2) high amount (67 KKW)/moderate intensity: equivalent of expending 67 KKW (∼22.3 km [13.8 miles] per week) with moderate-intensity exercise; (3) high amount (67 KKW)/vigorous intensity: equivalent to group 2, but with vigorous-intensity exercise (75% [Formula: see text]); and (4) diet + 42 KKW moderate intensity: same as group 1 but with diet and weight loss (7%) to mimic the first 6 months of the DPP. Computer-generated randomisation lists were provided by our statistician (G. P. Samsa). The randomisation list was maintained by L. H. Willis and C. A. Slentz with no knowledge of or input into the scheduling, whereas all scheduling was done by L. A. Bateman, with no knowledge of the randomisation list. Subjects were automatically assigned to the next group listed on the randomisation sheet (with no ability to manipulate the list order) on the day that they came in for the OGTT, by L. H. Willis. All plasma analysis was done blinded by the individuals doing the measurements (i.e. lipids, glucose, insulin). Subjects and research staff (other than individuals analysing the blood) were not blinded to the group assignments. RESULTS: Number randomised, completers and number analysed with complete OGTT data for each group were: low-amount/moderate-intensity (61, 43, 35); high-amount/moderate-intensity (61, 44, 40); high-amount/vigorous-intensity (61, 43, 38); diet/exercise (54, 45, 37), respectively. Only the diet and exercise group experienced a decrease in fasting glucose (p < 0.001). The means and 95% CIs for changes in fasting glucose (mmol/l) for each group were: high-amount/moderate-intensity -0.07 (-0.20, 0.06); high-amount/vigorous 0.06 (-0.07, 0.19); low-amount/moderate 0.05 (-0.05, 0.15); and diet/exercise -0.32 (-0.46, -0.18). The effects sizes for each group (in the same order) were: 0.17, 0.15, 0.18 and 0.71, respecively. For glucose tolerance (glucose AUC of OGTT), similar improvements were observed for the diet and exercise (8.2% improvement, effect size 0.73) and the 67 KKW moderate-intensity exercise (6.4% improvement, effect size 0.60) groups; moderate-intensity exercise was significantly more effective than the same amount of vigorous-intensity exercise (p < 0.0207). The equivalent amount of vigorous-intensity exercise alone did not significantly improve glucose tolerance (1.2% improvement, effect size 0.21). Changes in insulin AUC, fasting plasma glucose and insulin did not differ among the exercise groups and were numerically inferior to the diet and exercise group. CONCLUSIONS/INTERPRETATION: In the present clinical efficacy trial we found that a high amount of moderate-intensity exercise alone was very effective at improving oral glucose tolerance despite a relatively modest 2 kg change in body fat mass. These data, combined with numerous published observations of the strong independent relation between postprandial glucose concentrations and prediction of future diabetes, suggest that walking ∼18.2 km (22.3 km prescribed with 81.6% adherence in the 67 KKW moderate-intensity group) per week may be nearly as effective as a more intensive multicomponent approach involving diet, exercise and weight loss for preventing the progression to diabetes in prediabetic individuals. These findings have important implications for the choice of clinical intervention to prevent progression to type 2 diabetes for those at high risk. TRIAL REGISTRATION: ClinicalTrials.gov NCT00962962 FUNDING: The study was funded by National Institutes for Health National Institute of Diabetes and Digestive and Kidney Diseases (NIH-NDDK) (R01DK081559).

Effect of vitamin D supplementation on insulin resistance and glycaemic control in prediabetes: a systematic review and meta-analysis.

AIMS: To evaluate the effect of vitamin D on insulin resistance and glycaemic control in prediabetes. METHODS: A literature search was conducted of MEDLINE, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, Web of Science and www.clinicaltrials.gov, together with a historical search through the reference lists of relevant articles until end of June 2014. Studies were included if they were randomized controlled trials of vitamin D or vitamin D analogues in prediabetes and if they reported homeostatic model assessment of insulin resistance or 2-h plasma glucose after oral glucose tolerance test. Treatment effect was estimated according to mean difference in the changes from baseline of homeostatic model assessment of insulin resistance, 2-h oral glucose tolerance test plasma glucose, fasting plasma glucose and HbA1c between vitamin D and control groups. Meta-analysis of eligible studies was performed. RESULTS: A total of 10 randomized controlled trials were included. Vitamin D did not significantly improve homeostatic model assessment of insulin resistance and 2-h oral glucose tolerance test plasma glucose: the mean differences were -0.06 (95% CI -0.36 to 0.24) and -0.23 mmol/l (95% CI -0.65 to 0.19), respectively. Subgroup analysis suggested that vitamin D improved homeostatic model assessment of insulin resistance in a subgroup with baseline 25-hydroxyvitamin D ≥ 50 nmol/l [mean difference -0.59 (95% CI -1.14 to -0.04); P = 0.03] and improved 2-h oral glucose tolerance test plasma glucose in the subgroup with baseline 25-hydroxyvitamin D < 50 nmol/l [mean difference -0.68 mmol/l (95% CI -1.35 to -0.01); P = 0.05]. Vitamin D significantly reduced fasting plasma glucose and HbA1c levels. The mean differences were -0.10 mmol/l (95% CI -0.18 to -0.03), P = 0.006 and -1 mmol/mol (95% CI -2 to 0), P = 0.008, respectively. CONCLUSIONS: No beneficial effect of vitamin D in improving insulin resistance was identified.

Effects of total fibre or resistant starch-rich diets within lifestyle intervention in obese prediabetic adults.

PURPOSE: Starting from the evidence-based health benefits that resistant starch (RS) shows when added to the diet, our aim in this study was to evaluate the effects of increased fibre intake with two different levels of RS coming from regular daily consumed foods on normalization of glycaemia within lifestyle intervention in the population with risk factors for developing diabetes. METHODS: Study included 47 overweight and obese men and women with disordered glucoregulation and dyslipidaemia, aged between 45-74, divided into RS and Fibre group. Participants were subjected to the lifestyle and dietary intervention with low-fat and high-fibre (>25 g/day) diet for 12 months and were offered two different dietary advices aimed at increasing total fibre intake in Fibre group and at increasing RS intake in RS group. RESULTS: The intake of macronutrients and total fibre was similar between groups at the end of the study, but achieved RS intake was two times higher in the RS group. Decrease in total cholesterol and non-HDL-cholesterol was more pronounced in RS group in comparison with Fibre group (p = 0.010, p = 0.031, respectively), whereas in Fibre group, a more pronounced effect on glucoregulation was observed: significant fall in glycaemia after 2-h oral glucose tolerance test (7.93 vs 6.96 mmol/L, p = 0.034). CONCLUSION: At the end of the study, RS-rich diet failed to affect glycaemic control in prediabetic obese individuals in contrast to the regular fibre-rich diet, which indicated that fibre profile could be an important determinant of the effect of dietary intervention.