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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00635739
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
National Dairy Council
Information provided by (Responsible Party):
Roger A Fielding, Tufts University

Brief Summary:
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 or disease Intervention/treatment Phase
Mobility Limitation Dietary Supplement: Whey protein Dietary Supplement: Maltodextrin placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Lean Mass [ Time Frame: Baseline and follow up (6 months) ]
    Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   70 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  • Disorders of nutrient absorption
  • Milk, or whey allergy
  • Sulfa drugs and allergy to PABA-containing sunscreens

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00635739

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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
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Principal Investigator: Roger A Fielding, Ph.D. Jean Mayer USDA Human Nutrition Research Center on Aging

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Roger A Fielding, Director and Senior Scientist, Professor of Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging., Tufts University Identifier: NCT00635739    
Other Study ID Numbers: 1493
First Posted: March 14, 2008    Key Record Dates
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019
Last Verified: December 2018
Keywords provided by Roger A Fielding, Tufts University:
Whey protein
Resistance exercise
Physical activity
Mobility disability
Physical function
Muscle mass
Muscle strength
Older Adults
Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms