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.
- Conditions
- Overweight and ObesityPreDiabetesDiabetes Mellitus, Type 2
- Interventions
- Behavioral: Low-calorie and high-protein diet with the majority of protein coming from animal sources.Behavioral: Low-calorie and high-protein diet with the majority of protein coming from plant sources.
- Registration Number
- NCT05456347
- Lead Sponsor
- Universidad de Zaragoza
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Aged between 18 and 80.
- BMI between 27.5 kg/m2 and 40 kg/m2.
- Diagnosed as prediabetes or type 2 diabetes according to ADA criteria.
- Informed consent to be signed.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-protein animal diet. Low-calorie and high-protein diet with the majority of protein coming from animal sources. Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from animal sources (75% of total protein). High-protein vegetal diet. Low-calorie and high-protein diet with the majority of protein coming from plant sources. Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from plant sources (75% of total protein).
- Primary Outcome Measures
Name Time Method Insulin change. 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. 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. 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. 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.
Glucose change. 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.
Glycated hemoglobin change. 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. 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.
- Secondary Outcome Measures
Name Time Method HDL cholesterol change. After 3 and 6 months of intervention. HDL cholesterol change assessed by difference in fasting HDL cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Total cholesterol change. After 3 and 6 months of intervention. Total cholesterol change assessed by difference in fasting total cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
LDL cholesterol change. After 3 and 6 months of intervention. Total LDL cholesterol change assessed by difference in fasting LDL cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Triglycerides change. After 3 and 6 months of intervention. Triglycerides change assessed by difference in fasting triglycerides concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Trial Locations
- Locations (1)
Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
🇪🇸Zaragoza, Spain