Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults

This study is not yet open for participant recruitment.

Verified by Tufts University, March 2008

First Received: March 7, 2008 Last Updated: March 13, 2008 History of Changes

Sponsors and Collaborators:	Tufts University National Dairy Council
Information provided by:	Tufts University
ClinicalTrials.gov Identifier:	NCT00635739

Purpose

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.

Condition	Intervention
Mobility Limitation	Dietary Supplement: Whey protein Dietary Supplement: Maltodextrin placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Tufts University:

Primary Outcome Measures:

Muscle strength [ Time Frame: Baseline, mid-study and end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood pressure [ Time Frame: Baseline and end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 1: Active Comparator	Dietary Supplement: Whey protein powdered, 46g supplement dissolved in fluids, twice daily
A, 2: Placebo Comparator	Dietary Supplement: Maltodextrin placebo powdered, 46g supplement dissolved in fluids, twice daily

Eligibility

Ages Eligible for Study:	70 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and Females 70-85 yrs
Community dwelling
Short Physical Performance Battery score < 9
BMI = 21-31

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
Kidney Disease
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635739

Contacts

Contact: Roger A Fielding, Ph.D.

(617) 556-3016

roger.fielding@tufts.edu

Locations

United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Tufts University

National Dairy Council

Investigators

Principal Investigator:

Roger A Fielding, Ph.D.

Jean Mayer USDA Human Nutrition Research Center on Aging

More Information

No publications provided

Responsible Party:	Jean Mayer USDA Human Nutrition Research Center on Aging ( Roger Fielding, Director and Senior Scientist, Professor of Nutrition )
Study ID Numbers:	1493
Study First Received:	March 7, 2008
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00635739 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Tufts University:

Whey protein
Resistance exercise
Physical activity
Mobility disability
Physical function

Muscle mass
Muscle strength
Older Adults
Mobility-Limited

Study placed in the following topic categories:

Mobility Limitation
Signs and Symptoms
Whey Protein

Additional relevant MeSH terms:

Mobility Limitation
Signs and Symptoms

ClinicalTrials.gov processed this record on September 10, 2009