NCT06267235: LOWPRO

Dietary Protein Restriction and Health

Completed NA Last updated 7 May 2024

What this trial tests

NA trial testing Dietary protein restriction in Protein in 23 participants. Completed in 31 January 2024.

Timeline

1 May 2018

Primary endpoint
31 January 2020

31 January 2024

Quick facts

Lead sponsor	University of Copenhagen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	23
Start date	1 May 2018
Primary completion	31 January 2020
Estimated completion	31 January 2024
Sites	1 location across Denmark

Drugs / interventions tested

• Dietary protein restriction

Conditions studied

• Protein — all drugs for Protein →
• Healthy — all drugs for Healthy →
• Diet — all drugs for Diet →

Sponsor

University of Copenhagen

Who can join

Adults 25 to 35, male only, with Protein or Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. Dietary protein restriction elevates FGF21 levels and energy requirements to maintain body weight in lean men.
   Nicolaisen TS, Lyster AE, Sjøberg KA, Haas DT, et al · · 2025 · cited 15× · PMID 40050437 · DOI 10.1038/s42255-025-01236-7