NCT03285737

Brief Summary

Sarcopenia, the loss in muscle mass with age, is associated with several negative health outcomes including cancer, stroke, cardiovascular disease and diabetes. This loss of muscle mass remains relatively steady following 50 years of age however it can be accelerated with periods of disuse associated with hospitalization, fracture or surgery of the hip or simply influenza. Also associated with periods of disuse, is a lack of energy intake as hospitalizations often result in undernourishment. The consumption of protein has been shown to stimulate muscle growth and therefore the investigators are wondering whether it is able to offset the loss of muscle mass associated with disuse. Therefore, the purpose of the study is to examine the effects of protein consumption combined with mild caloric restriction on changes in muscle mass and function during a period of disuse as well as during a period of recovery .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

September 12, 2017

Last Update Submit

March 20, 2018

Conditions

AgingMuscle Loss

Keywords

Protein ingestionMuscle protein synthesis

Outcome Measures

Primary Outcomes (1)

  • Integrated myofibrillar muscle protein synthesis with use of deuterated water, measured by GCMS

    Measured with ingestion of deuterated water, looking at enrichments in total body water versus muscle

    5 weeks

Secondary Outcomes (7)

  • Rockport walk test (submaximal VO2 test)

    5 weeks

  • Marker of systemic inflammation (TNF-a)

    5 weeks

  • Fasted glucose

    5 weeks

  • Fasted insulin

    5 Weeks

  • Timed up and go test

    5 weeks

  • +2 more secondary outcomes

Study Arms (2)

Whey protein supplement

EXPERIMENTAL

Supplement will be delivered twice daily (30g per supplement) of whey protein isolate

Dietary Supplement: Whey

Collagen peptide supplement

ACTIVE COMPARATOR

Supplement will be delivered twice daily (30g per supplement) of hydrolyzed collagen peptides.

Dietary Supplement: Collagen

Interventions

WheyDIETARY_SUPPLEMENT

Supplement provided twice daily in 30g doses

Whey protein supplement
CollagenDIETARY_SUPPLEMENT

Supplement provided twice daily in 30g doses

Collagen peptide supplement

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Free of any chronic conditions
  • Non smoker
  • Non diabetic
  • No consumption of medications known to affect protein metabolism
  • No allergies to dairy proteins
  • Moderately active (3500-10,000 steps per day)
  • No use of a walker or assistive walking device

You may not qualify if:

  • Cigarette use, diabetic, non active, use of a walker, consumption of drugs known to affect protein metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

  • Oikawa SY, McGlory C, D'Souza LK, Morgan AK, Saddler NI, Baker SK, Parise G, Phillips SM. A randomized controlled trial of the impact of protein supplementation on leg lean mass and integrated muscle protein synthesis during inactivity and energy restriction in older persons. Am J Clin Nutr. 2018 Nov 1;108(5):1060-1068. doi: 10.1093/ajcn/nqy193.

    PMID: 30289425DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Interventions

WheyCollagen

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesBiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Stuart M Phillips, Ph.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel group design (with repeated measurements within each group)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 18, 2017

Study Start

March 23, 2016

Primary Completion

December 15, 2016

Study Completion

November 1, 2017

Last Updated

March 22, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)