A Randomized Study to Investigate the Effect of a Low-calorie and High-protein Diet Specially Rich in Animal Protein Compared to a Low-calorie and High-protein Diet Specially Rich in Plant Protein on Glucose Metabolism in Subjects With Prediabetes or Type 2 Diabetes and Overweight or Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Glucose change.
研究概览
简要总结
The aim of the study is to explore the effect of a low-calorie diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from animal sources (75% of total protein), compared to a hypocaloric diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from plant sources (75% of total proteins), in subjects with prediabetes or type 2 diabetes and overweight or obesity, on body composition, glucose and lipid metabolisms, after 6 months of intervention.
To achieve the objective, a nutritional intervention study is carried out by randomizing participants to: a) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from animal sources (75% of total protein); b) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from plant sources (75% of total protein). The study has a total duration of 6 months and include the assessment of clinical, anthropometric, biochemical and lifestyle parameters, at the beginning of the study and after 3 and 6 months of intervention.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and
- •BMI between 27.5 kg/m2 and 40 kg/m
- •Diagnosed as prediabetes or type 2 diabetes according to ADA criteria.
- •Informed consent to be signed.
排除标准
- •Taking antidiabetic drugs (except for metformin with stable dose in the previous 6 months).
- •Taking lipid-lowering drugs in unstable dose in the previous 2 months.
- •Taking functional foods (i.e. sterols enriched food) or any other dietary supplement with a significant effect on lipid and glucose metabolism and body weight.
- •Uncontrolled type 2 diabetes (i.e. glycated hemoglobin over 8%)
- •Any disease that could affect study results (i.e. uncontrolled hypothyroidism).
- •Alcohol intake over 30 g/day.
- •Pregnancy or breastfeeding.
- •Any other condition that investigators consider that could interfere with study outcomes.
结局指标
主要结局
Glucose change.
时间窗: After 3 and 6 months of intervention.
Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Insulin change.
时间窗: After 3 and 6 months of intervention.
Insulin change assessed by difference in fasting insulin concentration (UI/mL and %) comparing 3 and 6 months visits with respect to baseline.
HOMA-IR change.
时间窗: After 3 and 6 months of intervention.
HOMA-IR change assessed by difference in HOMA-IR concentration (absolute units and %) comparing 3 and 6 months visits with respect to baseline. HOMA-IR is calculated by calculating: \[(fasting glucose (mg/dL) x 0,0555) x fasting insulin (UI/ml)\] ÷ 22,5.
Fat-free mass change.
时间窗: After 3 and 6 months of intervention.
Fat-free mass change assessed by difference in fat free-mass (%) comparing 3 and 6 months visits with respect to baseline.
Visceral fat mass change.
时间窗: After 3 and 6 months of intervention.
Visceral fat mass change assessed by difference in visceral fat mass (kg and %) comparing 3 and 6 months visits with respect to baseline.
Glycated hemoglobin change.
时间窗: After 3 and 6 months of intervention.
Glycated hemoglobin change assessed by difference in glycated hemoglobin concentration (%) comparing 3 and 6 months visits with respect to baseline.
Body fat mass change.
时间窗: After 3 and 6 months of intervention.
Body fat mass change assessed by difference in fat mass (%) comparing 3 and 6 months visits with respect to baseline.
次要结局
- HDL cholesterol change.(After 3 and 6 months of intervention.)
- Total cholesterol change.(After 3 and 6 months of intervention.)
- LDL cholesterol change.(After 3 and 6 months of intervention.)
- Triglycerides change.(After 3 and 6 months of intervention.)
研究者
Rocio Mateo-Gallego
Principal Investigator
Universidad de Zaragoza