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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014