NCT06263725

Brief Summary

Prolonged dietary protein restriction has been shown to increase energy expenditure in mice simultaneously with an increase in plasma FGF21 levels. In overfeeding studies, a protein-restricted diet reduces weight gain in both mice and humans compared with normal and high-protein diets. Further, in energy balance studies, when lean men are provided with a protein-restricted diet for five weeks, an increase in energy intake was necessary to obtain their body weight. However, whether the effect of a protein-restricted diet is the same when consumed by overweight to obese men has divergent results in both mice and humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

February 8, 2024

Last Update Submit

February 8, 2024

Conditions

Diet, Healthy, Body Weight

Outcome Measures

Primary Outcomes (1)

  • Body weight

    The effect of a prolonged moderate protein-restricted diet on body weight in obese participants.

    5 weeks

Secondary Outcomes (1)

  • FGF21

    5 weeks

Study Arms (2)

Restricted dietary protein

EXPERIMENTAL

5 week intake of a isocaloric diet restricted in protein

Other: Restricted dietary proteinOther: Habitual diet

Habitul diet

EXPERIMENTAL

5 week intake of habitual, high protein diet

Other: Restricted dietary proteinOther: Habitual diet

Interventions

Restricted dietary proteinOTHER

Participants will be allocated to 5 week isocaloric restricted protein intake

Habitul dietRestricted dietary protein
Habitual dietOTHER

Participants will be follow their habitual, high protein intake

Habitul dietRestricted dietary protein

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 26 and 32 Low physical activity level Non-smoker Not using snuff Not suffering from diabetes, hypertension, or any daily medication use High protein intake (≥1,5 g/kg body weight/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bente Kiens, D.Sci

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

October 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

DK(1)