Optimal Protein Dose Per Meal During Weight Loss in Perspective to Maintaining Muscle Mass

Not Applicable

Completed

• Conditions: Protein Metabolism
• Interventions: Other: 35 g protein energy balance; Other: 15 g protein hypocaloric; Other: 35 g protein hypocaloric; Other: 60 g protein hypocaloric

• Registration Number: NCT03326284
• Lead Sponsor: University of Aarhus

Brief Summary

The primary aim of the trial is to determine the optimal dose of protein per meal in relation to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss during weight loss. In addition, we aim to determine whether the response to protein intake is reduced in women on hypocaloric diet compared to in women on an energy-balanced diet.

Detailed Description

Aim of this project is to determine the optimal protein dose (high quality milk protein) per meal in relation to enhancing muscle protein synthesis and thereby counteract muscle loss during weight loss.

The hypothesis is that the optimum dose of protein for women on a hypocaloric diet will be greater than when women eat an energy sufficient diet, and also higher than the optimal dose previously determined in weight stable men.

Methods: Forty women (\~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses. The muscle protein response to the different doses of protein will be determined by the muscle protein fractional synthetic rates using tracer kinetics.

Study Timeline

• Study First Submitted: 2017-05-08
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-31
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Status Verified: 2018-06
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• healthy
• Postmenopausal women

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Exclusion Criteria

• Smoking
• Metabolic and/or chronic diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
35g protein energy balanced diet	35 g protein energy balance	Following a 5-day energy balanced diet the subjects (n=10) will ingest 35g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics.
15g protein hypocaloric diet	15 g protein hypocaloric	Following a 5-day hypocaloric diet the subjects (n=10) will ingest 15g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics.
35g protein hypocaloric diet	35 g protein hypocaloric	Following a 5-day hypocaloric diet the subjects (n=10) will ingest 35g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics.
60g protein hypocaloric diet	60 g protein hypocaloric	Following a 5-day hypocaloric diet the subjects (n=10) will ingest 60g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics.

Primary Outcome Measures

Name	Time	Method
Fractional synthetic rate	3 hours after ingestion of protein	Mixed muscle protein synthetic rate determined by tracer kinetics

Secondary Outcome Measures

Name	Time	Method
Muscle signalling	3 hours after ingestion of protein.	Markers for myofibrillar protein turnover measured by RT-PCR and western blotting

Trial Locations

Locations (1)

Aarhus University, Department for Public Health, Section for Sport Science; 🇩🇰 Aarhus, Denmark