NCT02315391

Brief Summary

The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
Last Updated

December 18, 2014

Status Verified

November 1, 2014

Enrollment Period

1.2 years

First QC Date

November 12, 2014

Last Update Submit

December 17, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in myofibrillar fractional synthetic rate (FSR)

    one day and 2 weeks

Secondary Outcomes (2)

  • change in non-myofibrillar fractional synthetic rate (FSR)

    baseline and one day of feeding

  • Capillary dilatation and blood flow

    2 weeks

Study Arms (3)

20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine

EXPERIMENTAL

20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine

Dietary Supplement: isolated whey proteinDietary Supplement: glycine

20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine

EXPERIMENTAL

20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine

Dietary Supplement: micellar whey proteinDietary Supplement: glycine

20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline

EXPERIMENTAL

20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline

Dietary Supplement: micellar whey proteinDietary Supplement: citrulline

Interventions

isolated whey proteinDIETARY_SUPPLEMENT

isolated whey protein

20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine
micellar whey proteinDIETARY_SUPPLEMENT

micellar whey protein

20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline
glycineDIETARY_SUPPLEMENT

glycine

20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine
citrullineDIETARY_SUPPLEMENT

citrulline

20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline

Eligibility Criteria

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

You may qualify if:

  • Must habitually complete a minimum of 5000 steps per day
  • Having obtained informed consent
  • Non-obese
  • Non-smoker

You may not qualify if:

  • Aged \>80 years
  • Inability to comply with study procedures
  • Currently participating or having participated in another infusion trial during last 12 months
  • Any acute or chronic llness
  • History of neuromuscular problems
  • Medications known to affect protein metabolism
  • Individuals who complete fewer than 5000 steps per day
  • Individuals who have metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

GlycineCitrulline

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Diamino

Study Officials

  • Stuart Philips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

December 11, 2014

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 18, 2014

Record last verified: 2014-11