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Dietary Protein Restriction and Health

NCT06267235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-05-07

No results posted yet for this study

Summary

The incidence of type 2 diabetes worldwide has increased significantly over the past decades, which is associated with changing dietary habits and physical inactivity. According to the diet, so far there has been a great focus on the quality of carbohydrates and fat in relation to metabolic health, while the importance of protein has been neglected. The Danes' average protein intake is 1.5 g/kg/day, which is at the high end of the recommendations (0.8-1.5 g/kg/day) from the Nordic Nutrition Recommendations (NNR 2023). Recent studies in rodents have shown that protein restriction has positive effects on health, including improved glucose and insulin homeostasis and reduced fat mass, while a high intake of protein has a negative effect on insulin sensitivity. Previously the investigators have shown, in healthy young men, that consuming a diet low in protein (0.9 g/kg/day), compared to the participants usual diet (1.5 g/kg/day), over 7 days, resulted in an increased insulin sensitivity as well as a marked increase in the plasma fibroblast growth factor 21 (FGF21) concentration. The increased insulin sensitivity is thought to be mediated by the increase in plasma FGF21 concentration. However, the effect is not yet fully understood. It is also not clear whether the increase in plasma FGF21 concentration, as well as the mentioned metabolic effects on insulin and glucose homeostasis, will take place if the participants are kept weight stable on a eucaloric diet.

Conditions

  • Protein
  • Healthy
  • Diet

Interventions

OTHER

Dietary protein restriction

The consumption of different diets restricted in protein replaced by either carbohydrate or fat and an habitual diet.

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Bente Kiens, D.sci, PhD · University of Copenhagen

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-01-31
Completion
2024-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267235 on ClinicalTrials.gov