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

This study has been completed.
Sponsor:
Collaborator:
National Dairy Council
Information provided by (Responsible Party):
Roger A Fielding, Tufts University
ClinicalTrials.gov Identifier:
NCT00635739
First received: March 7, 2008
Last updated: May 30, 2012
Last verified: May 2012
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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:


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
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A, 1 Dietary Supplement: Whey protein
powdered, 46g supplement dissolved in fluids, twice daily
Placebo Comparator: A, 2 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:   Yes
Criteria

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

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 by Tufts University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roger A Fielding, Director and Senior Scientist, Professor of Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging., Tufts University
ClinicalTrials.gov Identifier: NCT00635739     History of Changes
Other Study ID Numbers: 1493
Study First Received: March 7, 2008
Last Updated: May 30, 2012
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

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014