NCT03281434

Brief Summary

With aging there is a natural loss of muscle mass and strength called sarcopenia, which increases the risk of falls and metabolic disease (i.e. Type II diabetes) and decreases the ability to perform activities of daily living. Eating protein and doing resistance exercise both increase the body's ability to make muscle protein, which is important to offset losses in muscle mass; however, older adults have a lower appetite and do not consume enough calories or protein to crease muscle and as such investigations in this population are needed. The amino acid (the building blocks of proteins) leucine is known to increase the ability of protein to make muscle. In this study we will investigate the ability of beverages with different types of protein and leucine to create muscle in older men and women whoa re particularly vulnerable to muscle losses and do not eat enough protein and are understudied in this area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

September 11, 2017

Last Update Submit

February 6, 2020

Conditions

Keywords

Skeletal muscleProtein synthesisProtein ingestionResistance exercise

Outcome Measures

Primary Outcomes (2)

  • Acute myofibrillar muscle protein synthesis

    Assessed with stable isotope tracer infusion (\[L-ring\] 13C6 phenylalanine)

    8 hours

  • Medium length myofibrillar muscle protein synthesis

    Assessed with deuterated water

    7 days

Secondary Outcomes (1)

  • Fasted glucose, insulin and oxidative stress (IL6, TNF-a, CRP)

    Assessed every 2 days throughout the 7 day monitoring period

Study Arms (2)

Collagen peptide

ACTIVE COMPARATOR

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

Dietary Supplement: Collagen peptide

Whey protein

EXPERIMENTAL

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

Dietary Supplement: Whey protein isolate

Interventions

Collagen peptideDIETARY_SUPPLEMENT

Low leucine content protein supplement to be consumed twice daily

Collagen peptide
Whey protein isolateDIETARY_SUPPLEMENT

High quality protein (DIAAS score), high leucine supplement, to be consumed twice daily

Whey protein

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Ambulatory, and able to perform exercise
  • Active (\~3500-10,000 steps per day)

You may not qualify if:

  • Smoker
  • Diabetic
  • Chronic conditions
  • Consumption of medications known to affect muscle protein synthesis
  • Statin myalgia
  • Allergy to milk protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Ivor Wynne Center

Hamilton, Ontario, L8S4K1, Canada

Location

Related Publications (1)

  • Oikawa SY, Kamal MJ, Webb EK, McGlory C, Baker SK, Phillips SM. Whey protein but not collagen peptides stimulate acute and longer-term muscle protein synthesis with and without resistance exercise in healthy older women: a randomized controlled trial. Am J Clin Nutr. 2020 Mar 1;111(3):708-718. doi: 10.1093/ajcn/nqz332.

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
OTHER
Intervention Model
PARALLEL
Model Details: Parallel group design (with repeated measurements within each group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

January 1, 2018

Primary Completion

August 30, 2018

Study Completion

August 1, 2019

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations