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Completed

NCT Number: NCT03326284

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

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.

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Key information

Conditions

Protein Metabolism

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy
  • Postmenopausal women

Exclusion criteria

  • Smoking
  • Metabolic and/or chronic diseases

Treatment and study plan

15 g protein hypocaloric

Other

Following a 5 day hypocaloric diet one group of 10 women will ingest 15 g of protein

35 g protein hypocaloric

Other

Following a 5 day hypocaloric diet one group of 10 women will ingest 35 g of protein

60 g protein hypocaloric

Other

Following a 5 day hypocaloric diet one group of 10 women will ingest 60 g of protein

35 g protein energy balance

Other

Following a 5 day energy balanced diet one group of 10 women will ingest 35 g of protein

Primary outcomes

  1. Fractional synthetic rate

    Time frame: 3 hours after ingestion of protein

    Mixed muscle protein synthetic rate determined by tracer kinetics

Secondary outcomes

  1. Muscle signalling

    Time frame: 3 hours after ingestion of protein.

    Markers for myofibrillar protein turnover measured by RT-PCR and western blotting

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Arla Foods
  • Innovation foundation
  • Mejeribrugets ForskningsFond

Registry information

Official study title

Optimizing Per Meal Protein Intake During Weight Loss

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2017
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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