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

Primary Purpose

Protein Metabolism

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

15 g protein hypocaloric

35 g protein hypocaloric

60 g protein hypocaloric

35 g protein energy balance

About this trial

This is an interventional prevention trial for Protein Metabolism focused on measuring Hypocaloric diet, Dietary protein

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

healthy
Postmenopausal women

Exclusion Criteria:

Smoking
Metabolic and/or chronic diseases

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

15g protein hypocaloric diet

35g protein hypocaloric diet

60g protein hypocaloric diet

35g protein energy balanced diet

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Fractional synthetic rate

Mixed muscle protein synthetic rate determined by tracer kinetics

Secondary Outcome Measures

Muscle signalling

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

Full Information

NCT ID

NCT03326284

First Posted

May 8, 2017

Last Updated

July 30, 2019

Sponsor

University of Aarhus

Collaborators

Arla Foods, Innovation foundation, Mejeribrugets ForskningsFond

1. Study Identification

Unique Protocol Identification Number

NCT03326284

Brief Title

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

Official Title

Optimizing Per Meal Protein Intake During Weight Loss

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

February 1, 2018 (Actual)

Study Completion Date

February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Arla Foods, Innovation foundation, Mejeribrugets ForskningsFond

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Protein Metabolism

Keywords

Hypocaloric diet, Dietary protein

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

: 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.

Masking

Participant

Masking Description

The protein doses provided will be masked. As all participants will receive the same amount and the drinks will taste similarly.

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

15g protein hypocaloric diet

Arm Type

Experimental

Arm Description

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.

Arm Title

35g protein hypocaloric diet

Arm Type

Experimental

Arm Description

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.

Arm Title

60g protein hypocaloric diet

Arm Type

Experimental

Arm Description

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.

Arm Title

35g protein energy balanced diet

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

15 g protein hypocaloric

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

35 g protein hypocaloric

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

60 g protein hypocaloric

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

35 g protein energy balance

Intervention Description

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

Primary Outcome Measure Information:

Title

Fractional synthetic rate

Description

Mixed muscle protein synthetic rate determined by tracer kinetics

Time Frame

3 hours after ingestion of protein

Secondary Outcome Measure Information:

Title

Muscle signalling

Description

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

Time Frame

3 hours after ingestion of protein.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: healthy Postmenopausal women Exclusion Criteria: Smoking Metabolic and/or chronic diseases

Facility Information:

Facility Name

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

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

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

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