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

Protein Metabolism Clinical Trial

Official title:

Optimizing Per Meal Protein Intake During Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326284
• Other study ID #: 57403
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: June 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• healthy

• Postmenopausal women

Exclusion Criteria:

• Smoking

• Metabolic and/or chronic diseases

Related Conditions & MeSH terms

• Protein Metabolism
• Weight Loss

Intervention

Other:
• 15 g protein hypocaloric
Following a 5 day hypocaloric diet one group of 10 women will ingest 15 g of protein
• 35 g protein hypocaloric
Following a 5 day hypocaloric diet one group of 10 women will ingest 35 g of protein
• 60 g protein hypocaloric
Following a 5 day hypocaloric diet one group of 10 women will ingest 60 g of protein
• 35 g protein energy balance
Following a 5 day energy balanced diet one group of 10 women will ingest 35 g of protein

Locations

Country	Name	City	State
Denmark	Aarhus University, Department for Public Health, Section for Sport Science	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Arla Foods, Innovation foundation, Mejeribrugets ForskningsFond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional synthetic rate	Mixed muscle protein synthetic rate determined by tracer kinetics	3 hours after ingestion of protein
Secondary	Muscle signalling	Markers for myofibrillar protein turnover measured by RT-PCR and western blotting	3 hours after ingestion of protein.