- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02315391
Protein Nutrition for Muscle Hypertrophy in Older Adults
December 17, 2014 updated by: Nestlé
Efficacy of Isolated Whey and Micellar Whey Protein (+/- Citrulline) to Stimulate Protein Synthesis in 'Healthy' and 'Anabolically Resistant' Elderly Muscle
The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly.
Study Overview
Status
Completed
Detailed Description
The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Must habitually complete a minimum of 5000 steps per day
- Having obtained informed consent
- Non-obese
- Non-smoker
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 20g isolated whey protein + 30g carb, 8,5g fat, 15g glycine
|
isolated whey protein
glycine
|
Experimental: 20g micellar whey protein + 30g carb, 8.5g fat, 15g glycine
|
glycine
micellar whey protein
|
Experimental: 20g micellar whey protein + 30g carb, 8.5g fat, 5g citrulline
|
micellar whey protein
citrulline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in myofibrillar fractional synthetic rate (FSR)
Time Frame: one day and 2 weeks
|
one day and 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in non-myofibrillar fractional synthetic rate (FSR)
Time Frame: baseline and one day of feeding
|
baseline and one day of feeding
|
|
Capillary dilatation and blood flow
Time Frame: 2 weeks
|
Determine if inactivity reduces the feeding-induced increase in capillary dilation and nutrient delivery and whether citrulline rescues this in "resistant" muscle or augments it in the "healthy" muscle as measured by Definity infusion and contrast enhanced ultrasound (CEUS)
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stuart Philips, PhD, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
November 12, 2014
First Submitted That Met QC Criteria
December 10, 2014
First Posted (Estimate)
December 11, 2014
Study Record Updates
Last Update Posted (Estimate)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 17, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11.06.NRC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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