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

December 4, 2018 updated by: Roger A Fielding, Tufts University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Jean Mayer USDA Human Nutrition Research Center on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A, 1
Dietary supplement: Whey protein
powdered, 46g supplement dissolved in fluids, twice daily
Placebo Comparator: A, 2
Dietary supplement: Maltodextrin placebo
powdered, 46g supplement dissolved in fluids, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and follow up (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lean Mass
Time Frame: Baseline and follow up (6 months)
Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
Baseline and follow up (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Collaborators

National Dairy Council

Investigators

  • Principal Investigator: Roger A Fielding, Ph.D., Jean Mayer USDA Human Nutrition Research Center on Aging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1493

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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