Effect of Dairy Products on Insulin Resistance in Overweight and Obese Individuals With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in whole-body insulin sensitivity
研究概览
简要总结
The objective of the study is to determine the effect of dairy consumption on insulin sensitivity in overweight and obese adults with prediabetes. Men and women (30-65 y) will be recruited from the greater Montreal area. Upon screening, those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 serving/d of reduced-fat dairy. Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d of reduced-fat or regular-fat dairy for 12 weeks. Participants will be instructed on how to incorporate foods into their diet in a manner that prevents changes in their body weight. The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome. In addition, glycemic variables, body composition, and cardiometabolic risk factors will be assessed as secondary outcomes. Serum lipidomic and global gene expression responses to the intervention in subcutaneous adipose tissue will be measured as exploratory variables. Adherence to intervention will be assessed at each visit by food diaries, a record of consumed dairy products, and serum proportion of 15:0, 17:0, and t16:1n7 fatty acids as objective biomarkers of dairy fat intake.
详细描述
The randomized controlled trial will be preceded by a 2-week run-in period in which participants will consume 1 serving/day of reduced-fat dairy. Following the run-in period, adherent participants will be randomly assigned to one of the three treatment groups (n=20 per group) in a 1:1:1 allocation ratio. Stratified permuted block randomization will be used to ensure adequate balance among groups using a computer-generated list of random numbers. Due to the nature of the test products, participants cannot be blinded to the diet intervention. However, outcome assessors will be blinded to treatment allocation.
During the screening visit, and after obtaining informed consent, eight, height, waist circumference, blood pressure, and pulse will be measured. Standard blood and urine tests, an OGTT, chest X-ray, electrocardiogram, and a physical exam will be performed. In addition, volunteers will be interviewed regarding demographic information, medical and family history, dietary habits, and physical activity using questionnaires.
At the run-in visit, participants will retrieve their dairy products and a dietitian will instruct them on how to incorporate incorporating 1 serving of reduced-fat dairy products each day into their habitual diet. Participants will be asked to record their food intake for 3 consecutive days (including one weekend day). They will also receive an accelerometer and instructions for use on the same 3-days they record their food intake. Participants will maintain a daily record of consumed dairy products during the run-in periods and throughout the study.
At the baseline and 12-week intervention visits, participants will undergo a hyperinsulinemic-euglycemic clamp to assess systemic insulin sensitivity. In addition, body composition will be measured by dual-energy X-ray absorptiometry and resting energy expenditure by indirect calorimetry. A biopsy of subcutaneous adipose tissue from the thigh will be taken at fasting.
During the 12-week intervention, participants in the limited dairy group will be instructed to limit their intake of dairy products to ≤1 serving/d of dairy. Participants in the 2-3 dairy servings of reduced or regular fat dairy groups will be provided with the study products. Serving sizes will be 250 mL milk, 175 g yogurt, and 50 g cheese. The dietitian will instruct participants individually on how to incorporate the dairy products into their habitual diets by reducing the intake of other foods of equivalent caloric content and complementary nutrient density, to maintain stable body weight. No additional dietary changes will be recommended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 30 and 65 years,
- •Able to provide informed consent,
- •Stable weight and dietary habits over a period of 3 months,
- •Body mass index of 25-40 kg/m2,
- •Waist circumference ≥94 cm for men, ≥80 cm for women,
- •One or more indicators of prediabetes:
- •5.7-6.4% HbA1c
- •fasting 5.6-6.9 mmol/L glucose, or
- •7.8-11.0 mmol/L glucose at 2-h OGTT
排除标准
- •Current smokers,
- •Pregnant or planning to become pregnant in the next 6 months,
- •Breastfeeding,
- •Participation in a weight loss program in the past 3 months,
- •Dairy allergy or lactose intolerance,
- •Any diagnosed eating disorders,
- •Substance abuse (drugs or alcohol >3 drinks/day),
- •Diagnosed medical conditions such as cardiovascular disease, anemia, kidney disease, liver disease and any cancer, other than skin, within 5 years.
- •Diabetes diagnosis,
- •Abnormal electrocardiogram or chest X-Ray,
- •Treatment with diuretics, certain β-blockers, bronchodilators, daily nonsteroidal anti-inflammatory drugs, anticoagulants or antiplatelet agents (except prophylactic aspirin 81 mg/d), antianginals, antiarrhythmics, oral steroids, or other medications known to affect glucose metabolism,
- •Refusal to temporarily stop taking supplements (vitamin D, calcium, multivitamins, herbal remedies),
- •Serum creatinine > 120 µmol/L,
- •Hemoglobin < 120 g/L,
- •Liver function tests ≥ 2× upper limit,
- •Positive viral serology,
- •Inaccessible veins.
研究组 & 干预措施
2-3 servings/day regular-fat
2-3 servings/day of regular-fat milk, yogurt, and cheese
干预措施: Regular fat dairy (Other)
≤1 dairy serving/day
Limited dairy intake
2-3 servings/day reduced-fat
2-3 servings/day of skim milk, fat-free yogurt, and low-fat cheese
干预措施: Reduced fat dairy (Other)
结局指标
主要结局
Change in whole-body insulin sensitivity
时间窗: Difference between baseline and 12-weeks intervention visit
Change in whole-body insulin sensitivity as measured by glucose infusion rate during the last 30 min of a hyperinsulinemic-euglycemic clamp divided by serum insulin concentration at the same period (M/I)
次要结局
- Change in oral disposition index(Difference between screening and 13-week follow-up visit)
- Change in glucose tolerance(Difference between screening and 13-week follow-up visit)
- Change in Insulinogenic index(Difference between screening and 13-week follow-up visit)
- Change in glycated hemoglobin(Difference between screening and 13-week follow-up visit)
- Change in systolic blood pressure(Difference between baseline and 12-weeks intervention visit)
- Change in total triglycerides(Difference between baseline and 12-weeks intervention visit)
- Change in total LDL-cholesterol(Difference between baseline and 12-weeks intervention visit)
- Change in total non-HDL-cholesterol(Difference between baseline and 12-weeks intervention visit)
- Change in Homeostatic Model Assessment for Insulin Resistance(Difference between screening and 13-week follow-up visit)
- Change in Matsuda index(Difference between screening and 13-week follow-up visit)
- Change in total lean body mass(Difference between baseline and 12-weeks intervention visit)
- Change in total fat mass(Difference between baseline and 12-weeks intervention visit)
- Change in visceral fat mass(Difference between baseline and 12-weeks intervention visit)
- Change in diastolic blood pressure(Difference between baseline and 12-weeks intervention visit)
- Change in total cholesterol(Difference between baseline and 12-weeks intervention visit)
- Change in total HDL-cholesterol(Difference between baseline and 12-weeks intervention visit)
- Change in C-reactive protein(Difference between baseline and 12-weeks intervention visit)
研究者
Sergio Burgos
Associate Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre