Dietary Protein Restriction and Health

NCT06267235 | Completed

• 1 other identifier: lowprotein
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Protein-restriction; FGF21; Energy; Insulin action

Outcome Measures

Primary Outcomes (2)

• Energy balance

  Energy balance was measured in an over-night fasted state via indirect calorimetry expressed in MJ/day prolonged eucaloric dietary protein restriction compared with a higher habitual protein intake

  from week 0 to week 10.

• Insulin sensitivity

  Insulin sensitivity was measured by the hyperinsulinemic, euglycemic clamp procedure

  Measured at week 5 (low protein, high carbohydrate diet) and week 5 on habitual diet and at week 5 (low protein high fat diet) and week 5 on habitual diet

Secondary Outcomes (2)

• Adipose tissue proteomics

  After 5 weeks low protein, high carbohydrate and 5 weeks low protein, high fat. On the tenth week on habitual diet

• Plasma FGF21

  Every week from week 0 to week 10

Study Arms (3)

Acute meal test

EXPERIMENTAL

acute intake of a low protein, high carbohydrate diet. No drug intervention

Other: Dietary protein restriction

Chronic low protein, high carbohydrate diet

EXPERIMENTAL

Low protein, high carbohydrate diet and habitual diet. No drug intervention

Other: Dietary protein restriction

Low protein , high fat diet

EXPERIMENTAL

Low protein, high fat diet and habitual diet. No drug intervention

Other: Dietary protein restriction

Interventions

Dietary protein restriction OTHER

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

Acute meal test; Chronic low protein, high carbohydrate diet; Low protein , high fat diet

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI≤25
• Maximal oxygen uptake ≤42-51 ml/kg/min) • non-smoking

You may not qualify if:

• The use of medicine

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

Study Officials

• Bente Kiens, D.sci, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Longitudinal study changing diet during the intervention 5 weeks restricted dietary protein + 5 weeks habitual dietary protein consumption

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 20, 2024
• Study Start: May 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

DK (1)