A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in glycated hemoglobin.
研究概览
简要总结
The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. Around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). Subjects are provided with weekly menus and different recipes to use them as part of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine samples are also collected to assess microalbuminuria and ureic nitrogen.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years old.
- •Body mass index between 27.5 -
- •Steady weight (± 4 kg) in the last 2 months.
- •Glycated hemoglobin between 6 - 7%.
排除标准
- •Anti-diabetic drugs (oral or subcutaneous) in the last 2 months.
- •Lipid-lowering drugs in the last 2 months.
- •Gouty arthritis in the last 2 years or uric acid > 735 mg/dl.
- •Presence of uncontrolled endocrinological pathology (including hypothyroidism).
- •Hepatic chronic disease (glomerular filtration rate < 45 ml/min).
- •Renal, inflammatory or tumoral diseases.
- •Drugs which could interfere in glucose or lipid metabolism such as androgens, corticosteroids (except for those with topic administration) and estrogen replacement therapy.
- •Intake of functional foods with plant sterols in the past 6 weeks.
- •High alcohol intake (> 30 g per day).
- •Any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study.
- •Pregnancy or intention of pregnancy during the study.
结局指标
主要结局
Change in glycated hemoglobin.
时间窗: After 3 and 6 months of intervention.
Change in insulin resistance (HOMA index).
时间窗: After 3 and 6 months of intervention.
Change in glucose.
时间窗: After 3 and 6 months of intervention.
次要结局
- Change in body composition.(After 3 and 6 months of intervention.)
- Change in waist circumference.(After 3 and 6 months of intervention.)
- Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins).(After 3 and 6 months of intervention.)
- Change in body weight.(After 3 and 6 months of intervention.)
研究者
Fernando Civeira
Professor
Instituto Aragones de Ciencias de la Salud
