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.

Completed NA Last updated 8 November 2022

What this trial tests

NA trial testing Low-calorie and high-protein diet with the majority of protein coming from animal sources. in Diabetes Mellitus, Type 2 in 120 participants. Completed in 1 November 2022.

Timeline

1 July 2021

Primary endpoint
1 October 2022

1 November 2022

Quick facts

Lead sponsor	Universidad de Zaragoza
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	1 July 2021
Primary completion	1 October 2022
Estimated completion	1 November 2022
Sites	1 location across Spain

Drugs / interventions tested

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

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Overweight and Obesity — all drugs for Overweight and Obesity →
• PreDiabetes — all drugs for PreDiabetes →

Sponsor

Universidad de Zaragoza — full company profile →

Who can join

Adults 18 to 80, any sex, with Diabetes Mellitus, Type 2 or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Rodrigo-Carbó C, Madinaveitia-Nisarre L, Pérez-Calahorra S, Gracia-Rubio I, et al · · 2025 · cited 6× · PMID 39420528 · DOI 10.1111/dom.16013