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

NCT ID: NCT03326284

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-02-01

Brief Summary

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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

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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.

Conditions

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Protein Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

: 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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

15 g protein hypocaloric

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

35 g protein hypocaloric

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

60 g protein hypocaloric

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

35 g protein energy balance

Intervention Type OTHER

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

Interventions

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15 g protein hypocaloric

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

Intervention Type OTHER

35 g protein hypocaloric

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

Intervention Type OTHER

60 g protein hypocaloric

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

Intervention Type OTHER

35 g protein energy balance

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy
* Postmenopausal women

Exclusion Criteria

* Smoking
* Metabolic and/or chronic diseases
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arla Foods

INDUSTRY

Sponsor Role collaborator

Innovation foundation

UNKNOWN

Sponsor Role collaborator

Mejeribrugets ForskningsFond

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Larsen MS, Witard OC, Holm L, Scaife P, Hansen R, Smith K, Tipton KD, Mose M, Bengtsen MB, Lauritsen KM, Mikkelsen UR, Hansen M. Dose-Response of Myofibrillar Protein Synthesis To Ingested Whey Protein During Energy Restriction in Overweight Postmenopausal Women: A Randomized, Controlled Trial. J Nutr. 2023 Nov;153(11):3173-3184. doi: 10.1016/j.tjnut.2023.08.011. Epub 2023 Aug 19.

Reference Type DERIVED
PMID: 37598750 (View on PubMed)

Other Identifiers

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57403

Identifier Type: -

Identifier Source: org_study_id

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