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

Tufts University

Status: Completed

Conditions: Mobility Limitation

Treatments: Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00635739

1493

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 70 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

A, 1

Active Comparator group

Treatment:

Dietary Supplement: Whey protein

A, 2

Placebo Comparator group

Treatment:

Dietary Supplement: Maltodextrin placebo