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Effects of Creatine Supplementation on Muscle Mass and Function Among Older Women Subjected to Resistance Training

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ClinicalTrials.gov Identifier: NCT02188849
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Daniel Bunout, University of Chile

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Muscle Weakness
Interventions Other: Resistance exercise training
Drug: Creatine
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Creatine Placebo
Hide Arm/Group Description

Creatine 5 g/ day

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Creatine: Creatine powder 5 g day

Maltodextrin 5 g/day to be dissolved in water

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Period Title: Overall Study
Started 25 25
Completed 22 17
Not Completed 3 8
Reason Not Completed
Lost to Follow-up             3             8
Arm/Group Title Creatine Placebo Total
Hide Arm/Group Description

Creatine 5 g/ day

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Creatine: Creatine powder 5 g day

Maltodextrin 5 g/day to be dissolved in water

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
67.5  (4.5) 68.1  (4.9) 67.8  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
25
 100.0%
25
 100.0%
50
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Chile Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Rectus Femoris Cross Sectional Height
Hide Description Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound
Time Frame Twelve weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine Placebo
Hide Arm/Group Description:

Creatine 5 g/ day

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Creatine: Creatine powder 5 g day

Maltodextrin 5 g/day to be dissolved in water

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Overall Number of Participants Analyzed 22 17
Mean (Standard Deviation)
Unit of Measure: cm
17.5  (2.0) 17.6  (2.8)
2.Secondary Outcome
Title Quadriceps Isometric Strength
Hide Description Measurement of quadriceps isometric force using a quadriceps table
Time Frame Twelve weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine Placebo
Hide Arm/Group Description:

Creatine 5 g/ day

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Creatine: Creatine powder 5 g day

Maltodextrin 5 g/day to be dissolved in water

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Overall Number of Participants Analyzed 22 17
Mean (Standard Deviation)
Unit of Measure: Newtons
278.6  (53.9) 225.3  (50.6)
3.Secondary Outcome
Title Twelve Minutes Walk
Hide Description Measurement of the distance that a participant can walk during 12 minutes
Time Frame Twelve weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine Placebo
Hide Arm/Group Description:

Creatine 5 g/ day

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Creatine: Creatine powder 5 g day

Maltodextrin 5 g/day to be dissolved in water

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Overall Number of Participants Analyzed 22 17
Mean (Standard Deviation)
Unit of Measure: meters
1091.4  (101.1) 1087.5  (108)
4.Other Pre-specified Outcome
Title Serum Creatinine
Hide Description Serum creatinine levels
Time Frame Twelve weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine Placebo
Hide Arm/Group Description:

Creatine 5 g/ day

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Creatine: Creatine powder 5 g day

Maltodextrin 5 g/day to be dissolved in water

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Overall Number of Participants Analyzed 22 17
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.8  (0.12) 0.75  (0.13)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Creatine Placebo
Hide Arm/Group Description

Creatine 5 g/ day

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

Creatine: Creatine powder 5 g day

Maltodextrin 5 g/day to be dissolved in water

Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.

All-Cause Mortality
Creatine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Creatine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Creatine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/22 (50.00%)      8/17 (47.06%)    
Gastrointestinal disorders     
Gastroinftestinal symptoms   3/22 (13.64%)  4 2/17 (11.76%)  3
Infections and infestations     
Fever   1/22 (4.55%)  1 0/17 (0.00%)  0
Injury, poisoning and procedural complications     
Falls   3/22 (13.64%)  3 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders     
Pain   4/22 (18.18%)  5 5/17 (29.41%)  6
Indicates events were collected by systematic assessment
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: Sandra Hirsch MD
Organization: Institute of Nutrition and Food Technology University of Chile
Phone: +56 229781485
EMail: shirsch@inta.uchile.cl
Layout table for additonal information
Responsible Party: Daniel Bunout, University of Chile
ClinicalTrials.gov Identifier: NCT02188849    
Other Study ID Numbers: Creatine elderly
Creatine INTA ( Other Identifier: INTA U de Chile )
First Submitted: July 10, 2014
First Posted: July 14, 2014
Results First Submitted: October 1, 2015
Results First Posted: October 30, 2015
Last Update Posted: October 30, 2015