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.

Not Applicable

Completed

• Conditions: Overweight and Obesity; PreDiabetes; Diabetes Mellitus, Type 2

• 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

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Primary Completion: 2022-10-01
• Status Verified: 2022-11
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

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