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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Mobility Limitation
Interventions Dietary Supplement: Whey protein
Dietary Supplement: Maltodextrin placebo
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Whey Protein Placebo
Hide Arm/Group Description Whey protein: powdered, 46g supplement dissolved in fluids, twice daily Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
Period Title: Overall Study
Started 42 38
Completed 39 36
Not Completed 3 2
Arm/Group Title A,1 (Intervention) A,2 (Control) Total
Hide Arm/Group Description Whey protein: powdered, 46g supplement dissolved in fluids, twice daily Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily Total of all reporting groups
Overall Number of Baseline Participants 42 38 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 38 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
42
 100.0%
38
 100.0%
80
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 38 participants 80 participants
78.0  (4.0) 77.3  (3.9) 77.7  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 38 participants 80 participants
Female
25
  59.5%
22
  57.9%
47
  58.8%
Male
17
  40.5%
16
  42.1%
33
  41.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 38 participants 80 participants
42 38 80
1.Primary Outcome
Title 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects were not included in follow up analysis
Arm/Group Title Whey Protein Placebo
Hide Arm/Group Description:
Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
Overall Number of Participants Analyzed 42 38
Mean (Standard Deviation)
Unit of Measure: N
Baseline Number Analyzed 42 participants 38 participants
1223  (380) 1256  (461)
Follow up Number Analyzed 39 participants 36 participants
1483  (517) 1465  (528)
2.Secondary Outcome
Title Lean Mass
Hide Description Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
Time Frame Baseline and follow up (6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects were not included in follow up analysis
Arm/Group Title Whey Protein Placebo
Hide Arm/Group Description:
Whey protein: powdered, 46g supplement dissolved in fluids, twice daily
Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
Overall Number of Participants Analyzed 42 38
Mean (Standard Deviation)
Unit of Measure: Kg
Baseline Number Analyzed 42 participants 38 participants
46.7  (8.6) 46.4  (8.4)
Follow up Number Analyzed 39 participants 36 participants
47.3  (8.6) 46.7  (8.4)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Whey Protein Placebo
Hide Arm/Group Description Whey protein: powdered, 46g supplement dissolved in fluids, twice daily Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
All-Cause Mortality
Whey Protein Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Whey Protein Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/42 (14.29%)      3/38 (7.89%)    
Cardiac disorders     
Cardiovascular   2/42 (4.76%)  1/38 (2.63%) 
General disorders     
fall   1/42 (2.38%)  1/38 (2.63%) 
hospitalization  [1]  3/42 (7.14%)  1/38 (2.63%) 
Indicates events were collected by systematic assessment
[1]
Hospitalization reason is not know.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Whey Protein Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/42 (33.33%)      19/38 (50.00%)    
Gastrointestinal disorders     
GI distress  [1]  4/42 (9.52%)  4 2/38 (5.26%)  2
General disorders     
Laboratory  [2]  3/42 (7.14%)  3 1/38 (2.63%)  1
Illness  [3]  5/42 (11.90%)  5 6/38 (15.79%)  6
Musculoskeletal and connective tissue disorders     
Fall  [4]  0/42 (0.00%)  0 2/38 (5.26%)  2
Musculoskeletal  [5]  1/42 (2.38%)  1 3/38 (7.89%)  3
Surgical and medical procedures     
Surgery  [6]  1/42 (2.38%)  1 5/38 (13.16%)  5
Indicates events were collected by systematic assessment
[1]
GI upset
[2]
Abnormal laboratory value
[3]
Illness that would restrict physical activity
[4]
Non-injurious fall
[5]
Musculoskeletal pain/injury
[6]
Outpatient surgical procedure
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Roger Fielding
Organization: Tufts University
Phone: 6175563083
EMail: Roger.Fielding@tufts.edu
Layout table for additonal information
Responsible Party: Roger A Fielding, Tufts University
ClinicalTrials.gov Identifier: NCT00635739     History of Changes
Other Study ID Numbers: 1493
First Submitted: March 7, 2008
First Posted: March 14, 2008
Results First Submitted: May 26, 2017
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019