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

Mobility Limitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635739
• Other study ID #: 1493
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: May 2011

Study information

• Verified date: December 2018
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

Dietary Supplement:
• Whey protein
powdered, 46g supplement dissolved in fluids, twice daily
• Maltodextrin placebo
powdered, 46g supplement dissolved in fluids, twice daily

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	National Dairy Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press	The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.	Baseline and follow up (6 months)
Secondary	Lean Mass	Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.	Baseline and follow up (6 months)