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

Primary Purpose

Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey protein
Maltodextrin placebo
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mobility Limitation focused on measuring Whey protein, Resistance exercise, Physical activity, Mobility disability, Physical function, Muscle mass, Muscle strength, Older Adults, Mobility-Limited

Eligibility Criteria

70 Years - 85 Years (Older Adult)All SexesAccepts 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

Sites / Locations

  • Jean Mayer USDA Human Nutrition Research Center on Aging

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A, 1

A, 2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2008
Last Updated
December 4, 2018
Sponsor
Tufts University
Collaborators
National Dairy Council
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1. Study Identification

Unique Protocol Identification Number
NCT00635739
Brief Title
Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults
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 Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
National Dairy Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
Keywords
Whey protein, Resistance exercise, Physical activity, Mobility disability, Physical function, Muscle mass, Muscle strength, Older Adults, Mobility-Limited

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A, 1
Arm Type
Active Comparator
Arm Title
A, 2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
powdered, 46g supplement dissolved in fluids, twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin placebo
Intervention Description
powdered, 46g supplement dissolved in fluids, twice daily
Primary Outcome Measure Information:
Title
1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
Description
The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.
Time Frame
Baseline and follow up (6 months)
Secondary Outcome Measure Information:
Title
Lean Mass
Description
Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
Time Frame
Baseline and follow up (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger A Fielding, Ph.D.
Organizational Affiliation
Jean Mayer USDA Human Nutrition Research Center on Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23114462
Citation
Chale A, Cloutier GJ, Hau C, Phillips EM, Dallal GE, Fielding RA. Efficacy of whey protein supplementation on resistance exercise-induced changes in lean mass, muscle strength, and physical function in mobility-limited older adults. J Gerontol A Biol Sci Med Sci. 2013 Jun;68(6):682-90. doi: 10.1093/gerona/gls221. Epub 2012 Oct 31.
Results Reference
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Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults

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