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.

University of Zaragoza

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05456347

PI19/485

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

High-protein animal diet.

Experimental group

Description:

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

Treatment:

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

High-protein vegetal diet.

Experimental group

Description:

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

Treatment:

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