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

Optimizing Per Meal Protein Intake During Weight Loss

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.

Study Overview

• Status: Completed
• Conditions: Protein Metabolism
• Intervention / Treatment: Other: 15 g protein hypocaloric; Other: 35 g protein hypocaloric; Other: 60 g protein hypocaloric; Other: 35 g protein energy balance

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University, Department for Public Health, Section for Sport Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• healthy
• Postmenopausal women

Exclusion Criteria:

• Smoking
• Metabolic and/or chronic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15g protein hypocaloric diet; 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.	Other: 15 g protein hypocaloric; Following a 5 day hypocaloric diet one group of 10 women will ingest 15 g of protein
Experimental: 35g protein hypocaloric diet; 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.	Other: 35 g protein hypocaloric; Following a 5 day hypocaloric diet one group of 10 women will ingest 35 g of protein
Experimental: 60g protein hypocaloric diet; 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.	Other: 60 g protein hypocaloric; Following a 5 day hypocaloric diet one group of 10 women will ingest 60 g of protein
Experimental: 35g protein energy balanced diet; 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.	Other: 35 g protein energy balance; Following a 5 day energy balanced diet one group of 10 women will ingest 35 g of protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional synthetic rate	Mixed muscle protein synthetic rate determined by tracer kinetics	3 hours after ingestion of protein

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle signalling	Markers for myofibrillar protein turnover measured by RT-PCR and western blotting	3 hours after ingestion of protein.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Arla Foods; Mejeribrugets ForskningsFond; Innovation foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Dietary protein; Hypocaloric diet
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 57403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No