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

NCT03326284 | Completed DMC

• 1 other identifier: 57403
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Protein Metabolism

Keywords

Hypocaloric diet; Dietary protein

Outcome Measures

Primary Outcomes (1)

• Fractional synthetic rate

  Mixed muscle protein synthetic rate determined by tracer kinetics

  3 hours after ingestion of protein

Secondary Outcomes (1)

• Muscle signalling

  3 hours after ingestion of protein.

Study Arms (4)

15g protein hypocaloric diet

EXPERIMENTAL

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

35g protein hypocaloric diet

EXPERIMENTAL

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

60g protein hypocaloric diet

EXPERIMENTAL

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

35g protein energy balanced diet

EXPERIMENTAL

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

Interventions

15 g protein hypocaloric OTHER

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

15g protein hypocaloric diet

35 g protein hypocaloric OTHER

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

35g protein hypocaloric diet

60 g protein hypocaloric OTHER

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

60g protein hypocaloric diet

35 g protein energy balance OTHER

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

35g protein energy balanced diet

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy
• Postmenopausal women

You may not qualify if:

• Smoking
• Metabolic and/or chronic diseases

Sponsors & Collaborators

• University of Aarhus: lead
• Arla Foods: collaborator
• Innovation foundation: collaborator
• Mejeribrugets ForskningsFond: collaborator

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37598750 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The protein doses provided will be masked. As all participants will receive the same amount and the drinks will taste similarly.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: : 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.

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: October 31, 2017
• Study Start: August 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 31, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)