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Completed

NCT Number: NCT00635739

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

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.

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Key information

Conditions

Mobility Limitation Behavior Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein

Dietary Supplement

powdered, 46g supplement dissolved in fluids, twice daily

Maltodextrin placebo

Dietary Supplement

powdered, 46g supplement dissolved in fluids, twice daily

Primary outcomes

  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 outcomes

  1. Lean Mass

    Time frame: Baseline and follow up (6 months)

    Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Dairy Council

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 14, 2008
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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