- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00635739
Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults
December 4, 2018 updated by: Roger A Fielding, Tufts University
Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults
This research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Jean Mayer USDA Human Nutrition Research Center on Aging
-
-
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
70 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and Females 70-85 yrs
- Community dwelling
- Short Physical Performance Battery score < 10
- BMI = 21-32.5
Exclusion Criteria:
- Acute or terminal illness
- Mini Mental State Exam < 23
- Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure
- Upper or lower extremity fracture in previous 6 months
- Uncontrolled hypertension (>150/90 mm Hg).
- Neuromuscular diseases and drugs which affect neuromuscular function.
- Hormone replacement therapy
- eGFR <30 mL/min/1.73m2
- Types I and II Diabetes Mellitus
- Dietary protein intake < 0.8 g.kg-1.day-1
- Disorders of nutrient absorption
- Milk, or whey allergy
- Sulfa drugs and allergy to PABA-containing sunscreens
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A, 1
|
powdered, 46g supplement dissolved in fluids, twice daily
|
Placebo Comparator: A, 2
|
powdered, 46g supplement dissolved in fluids, twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
Time Frame: Baseline and follow up (6 months)
|
The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.
|
Baseline and follow up (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lean Mass
Time Frame: Baseline and follow up (6 months)
|
Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
|
Baseline and follow up (6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Roger A Fielding, Ph.D., Jean Mayer USDA Human Nutrition Research Center on Aging
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2008
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
March 7, 2008
First Submitted That Met QC Criteria
March 13, 2008
First Posted (Estimate)
March 14, 2008
Study Record Updates
Last Update Posted (Actual)
March 18, 2019
Last Update Submitted That Met QC Criteria
December 4, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1493
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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