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Clinical Trials/NCT00635739
NCT00635739CompletedNot Applicable

Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults

Tufts University1 site in 1 country80 target enrollmentStarted: April 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
70 Years to 85 Years (Older Adult)
Sex
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 g.kg-1.day-1
  • Disorders of nutrient absorption
  • Milk, or whey allergy
  • Sulfa drugs and allergy to PABA-containing sunscreens

Arms & Interventions

A, 2

Placebo Comparator

Intervention: Maltodextrin placebo (Dietary Supplement)

A, 1

Active Comparator

Intervention: Whey protein (Dietary Supplement)

Outcomes

Primary Outcomes

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 Outcomes

  • Lean Mass(Baseline and follow up (6 months))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Roger A Fielding

Director and Senior Scientist, Professor of Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging.

Tufts University

Study Sites (1)

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