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.

NCT05456347 | Completed

• 1 other identifier: PI19/485
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Overweight and Obesity; PreDiabetes

Outcome Measures

Primary Outcomes (7)

• Glucose change.

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

  After 3 and 6 months of intervention.

• Glycated hemoglobin change.

  Glycated hemoglobin change assessed by difference in glycated hemoglobin concentration (%) comparing 3 and 6 months visits with respect to baseline.

  After 3 and 6 months of intervention.

• Insulin change.

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

  After 3 and 6 months of intervention.

• HOMA-IR change.

  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.

  After 3 and 6 months of intervention.

• Body fat mass change.

  Body fat mass change assessed by difference in fat mass (%) comparing 3 and 6 months visits with respect to baseline.

  After 3 and 6 months of intervention.

• Fat-free mass change.

  Fat-free mass change assessed by difference in fat free-mass (%) comparing 3 and 6 months visits with respect to baseline.

  After 3 and 6 months of intervention.

• Visceral fat mass change.

  Visceral fat mass change assessed by difference in visceral fat mass (kg and %) comparing 3 and 6 months visits with respect to baseline.

  After 3 and 6 months of intervention.

Secondary Outcomes (4)

• Total cholesterol change.

  After 3 and 6 months of intervention.

• LDL cholesterol change.

  After 3 and 6 months of intervention.

• HDL cholesterol change.

  After 3 and 6 months of intervention.

• Triglycerides change.

  After 3 and 6 months of intervention.

Other Outcomes (9)

• C-reactive protein change.

  After 3 and 6 months of intervention.

• Liver enzymes change.

  After 3 and 6 months of intervention.

• Uric acid change.

  After 3 and 6 months of intervention.

Study Arms (2)

High-protein animal diet.

EXPERIMENTAL

Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from animal sources (75% of total protein).

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

High-protein vegetal diet.

EXPERIMENTAL

Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from plant sources (75% of total protein).

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

Interventions

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.

High-protein animal diet.

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.

High-protein vegetal diet.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

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

Zaragoza, 50009, Spain

Location

Related Publications (1)

• Rodrigo-Carbo C, Madinaveitia-Nisarre L, Perez-Calahorra S, Gracia-Rubio I, Cebollada A, Galindo-Lalana C, Mateo-Gallego R, Lamiquiz-Moneo I. Low-calorie, high-protein diets, regardless of protein source, improve glucose metabolism and cardiometabolic profiles in subjects with prediabetes or type 2 diabetes and overweight or obesity. Diabetes Obes Metab. 2025 Jan;27(1):268-279. doi: 10.1111/dom.16013. Epub 2024 Oct 17.

  PMID: 39420528 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Prediabetic State

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 13, 2022
• Study Start: July 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)