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.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Universidad de Zaragoza · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Low-calorie and high-protein diet with the majority of protein coming from animal sources.	Diet was prescribed to the participant and menus and recipes were also provided.
BEHAVIORAL	Low-calorie and high-protein diet with the majority of protein coming from plant sources.	Diet was prescribed to the participant and menus and recipes were also provided.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-10-01
• Completion: 2022-11-01
• First posted: 2022-07-13
• Last updated: 2022-11-08

Locations

1 site across 1 country: Spain