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Clinical Trials/NCT06263725
NCT06263725CompletedNot Applicable

Protein Restriction (PR) for Weight Loss

University of Copenhagen2 sites in 1 country15 target enrollmentStarted: October 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
2
Primary Endpoint
Body weight

Study Overview

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.

Detailed Description

The present study is a randomised intervention study. Inclusion criteria for the study are healthy males age between 25 and 45 years, BMI between 26 and 32, low physical activity level (low aerobic capacity with a VO2 - peak of 30 ± 10 mL/min/kg), non-smoker, not using snuff, not suffering from diabetes, hypertension, or any daily medication use and a high dietary protein intake (≥1,5 g/kg body weight/day). Before the intervention period, the participants complete a two-week run-in period. The run-in period is designed to collect more detailed information about the participant's habitual diet, body weight, and physical activity pattern, as well as habituate the participants in the various tasks they have to complete during the intervention. Then a five-week intervention period is initiated where the participants are randomized to follow one of the following diets for 5 weeks: 1) a diet reduced in protein, replaced by primary carbohydrates (11 E% Protein, 50 E% carbohydrates, 37 E% fat), and 2) a control diet comprising habitual protein content (21E% Protein, 40 E% carbohydrates, 37 E% fat).

In the five-week intervention period, all food and drinks (besides water and coffee) are provided for the participant. All food is weighed to 1 gram of accuracy in meal portions for a seven-day cycle and is delivered to the participant.

During the intervention the volunteers participate in six test days, one every week during the intervention. 48 hours prior to the weekly test, the participants are asked to abstaine from vigorous physical activity. On all the test days, the participants arrive in the morning in a fasted state (no food or drink after 10 pm the night before) by passive transportation.

On the first test day (WT0), body composition is determined by DXA scan, and the total body water content is measured using bioimpedance analysis. Then resting metabolic rate is measured. Still, in the supine position, a blood sample is obtained from an antecubital vein. Biopsies are taken at baseline and at the end of the intervention (WT5). A fat biopsy is obtained from periumbilical subcutaneous adipose tissue and a muscle biopsy from the vastus lateralis muscle. On test day 3, halfway through the intervention, body composition, body water, and resting metabolic rate are measured, and blood is sampled from an antecubital vein. On week tests 1, 2, and 4, resting metabolic rate is measured, and blood sampled. At all visits to the institute, body weight is also measured.

During the intervention the participants wear a Sens motion sensor to monitor daily activity level.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
25 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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)

Exclusion Criteria

  • Not provided

Arms & Interventions

Restricted dietary protein

Experimental

5 week intake of a isocaloric diet restricted in protein

Intervention: Restricted dietary protein (Other)

Restricted dietary protein

Experimental

5 week intake of a isocaloric diet restricted in protein

Intervention: Habitual diet (Other)

Habitul diet

Experimental

5 week intake of habitual, high protein diet

Intervention: Restricted dietary protein (Other)

Habitul diet

Experimental

5 week intake of habitual, high protein diet

Intervention: Habitual diet (Other)

Outcomes

Primary Outcomes

Body weight

Time Frame: 5 weeks

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

Secondary Outcomes

  • FGF21(5 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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