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Trial record 5 of 54 for:    whey protein | maltodextrin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00635739
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
National Dairy Council
Information provided by (Responsible Party):
Roger A Fielding, Tufts University

Tracking Information
First Submitted Date  ICMJE March 7, 2008
First Posted Date  ICMJE March 14, 2008
Results First Submitted Date  ICMJE May 26, 2017
Results First Posted Date  ICMJE March 18, 2019
Last Update Posted Date March 18, 2019
Study Start Date  ICMJE April 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
Muscle strength [ Time Frame: Baseline, mid-study and end of study ]
Change History Complete list of historical versions of study NCT00635739 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
Lean Mass [ Time Frame: Baseline and follow up (6 months) ]
Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
Blood pressure [ Time Frame: Baseline and end of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults
Official Title  ICMJE Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Mobility Limitation
Intervention  ICMJE
  • Dietary Supplement: Whey protein
    powdered, 46g supplement dissolved in fluids, twice daily
  • Dietary Supplement: Maltodextrin placebo
    powdered, 46g supplement dissolved in fluids, twice daily
Study Arms  ICMJE
  • Active Comparator: A, 1
    Intervention: Dietary Supplement: Whey protein
  • Placebo Comparator: A, 2
    Intervention: Dietary Supplement: Maltodextrin placebo
Publications * Chalé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00635739
Other Study ID Numbers  ICMJE 1493
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roger A Fielding, Tufts University
Study Sponsor  ICMJE Tufts University
Collaborators  ICMJE National Dairy Council
Investigators  ICMJE
Principal Investigator: Roger A Fielding, Ph.D. Jean Mayer USDA Human Nutrition Research Center on Aging
PRS Account Tufts University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP