NCT00635739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

March 18, 2019

Completed
Last Updated

March 18, 2019

Status Verified

December 1, 2018

Enrollment Period

3.1 years

First QC Date

March 7, 2008

Results QC Date

May 26, 2017

Last Update Submit

December 4, 2018

Conditions

Mobility Limitation

Keywords

Whey proteinResistance exercisePhysical activityMobility disabilityPhysical functionMuscle massMuscle strengthOlder AdultsMobility-Limited

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Lean Mass

    Baseline and follow up (6 months)

Study Arms (2)

A, 1

ACTIVE COMPARATOR
Dietary Supplement: Whey protein

A, 2

PLACEBO COMPARATOR
Dietary Supplement: Maltodextrin placebo

Interventions

Whey proteinDIETARY_SUPPLEMENT

powdered, 46g supplement dissolved in fluids, twice daily

A, 1
Maltodextrin placeboDIETARY_SUPPLEMENT

powdered, 46g supplement dissolved in fluids, twice daily

A, 2

Eligibility Criteria

Age70 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male and Females 70-85 yrs
  • Community dwelling
  • Short Physical Performance Battery score \< 10
  • BMI = 21-32.5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • 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.

    PMID: 23114462DERIVED

MeSH Terms

Conditions

Mobility LimitationMotor Activity

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Roger Fielding
Organization
Tufts University
Roger.Fielding@tufts.edu
6175563083

Study Officials

  • Roger A Fielding, Ph.D.

    Jean Mayer USDA Human Nutrition Research Center on Aging

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Senior Scientist, Professor of Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging.

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 18, 2019

Results First Posted

March 18, 2019

Record last verified: 2018-12

Locations

US(1)