Skip to main content
OpenTrials
Completed

NCT Number: NCT05456347

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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-calorie and high-protein diet with the majority of protein coming from animal sources.

Behavioral

Diet was prescribed to the participant and menus and recipes were also provided.

Low-calorie and high-protein diet with the majority of protein coming from plant sources.

Behavioral

Diet was prescribed to the participant and menus and recipes were also provided.

Primary outcomes

  1. Glucose change.

    Time frame: 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.

  2. Glycated hemoglobin change.

    Time frame: 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.

  3. Insulin change.

    Time frame: 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.

  4. HOMA-IR change.

    Time frame: 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.

  5. Body fat mass change.

    Time frame: 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.

  6. Fat-free mass change.

    Time frame: 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.

  7. Visceral fat mass change.

    Time frame: 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.

Secondary outcomes

  1. Total cholesterol change.

    Time frame: 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.

  2. LDL cholesterol change.

    Time frame: 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.

  3. HDL cholesterol change.

    Time frame: 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.

  4. Triglycerides change.

    Time frame: 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.

Other outcomes

  1. C-reactive protein change.

    Time frame: After 3 and 6 months of intervention.

    C-reactive protein change assessed by difference in fasting C-reactive protein concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.

  2. Liver enzymes change.

    Time frame: After 3 and 6 months of intervention.

    Liver enzymes (GGT, GOT and GPT) change assessed by difference in fasting liver enzymes concentration (U/L and %) comparing 3 and 6 months visits with respect to baseline.

  3. Uric acid change.

    Time frame: After 3 and 6 months of intervention.

    Uric acid change assessed by difference in fasting uric acid concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.

  4. GLP-1 change.

    Time frame: After 3 and 6 months of intervention.

    GLP-1 change assessed by difference in fasting GLP-1 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.

  5. GIP change.

    Time frame: After 3 and 6 months of intervention.

    GIP change assessed by difference in fasting GIP concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.

  6. IL-6 change.

    Time frame: After 3 and 6 months of intervention.

    IL-6 change assessed by difference in fasting IL-6 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.

  7. Leptin change.

    Time frame: After 3 and 6 months of intervention.

    Leptin change assessed by difference in fasting leptin concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.

  8. MCP1 change.

    Time frame: After 3 and 6 months of intervention.

    MCP1 change assessed by difference in fasting MCP1 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.

  9. TNF-alpha change.

    Time frame: After 3 and 6 months of intervention.

    TNF-alpha change assessed by difference in fasting TNF-alpha concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.