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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

Brief Summary:
To determine, in a double blind trial, the effects of creatine supplementation during 12 weeks on muscle mass and function of community living older women subjected to resistance training. Material and methods: Fifty healthy older women will be selected for the study. All participants will be subjected to a progressive resistance training program using elastic bands and weights, consisting in three sessions per week lasting 1 hour. Participant will be randomly allocated in a double blind fashion, to receive creatine 5 g per day or an identical placebo. The training and supplementation period will last 12 weeks. At baseline and at the end of the study, body composition will be measured by dual energy x-ray absorptiometry, rectus femoris cross sectional height and surface will be measured by ultrasound, quadriceps strength will be measured in a quadriceps table and 12 minutes' walk will be assessed. The main outcome measure will be quadriceps cross sectional height. Expected results: We expect that creatine supplementation will increase rectus femoris height over and above the effect of resistance training.

Condition or disease Intervention/treatment Phase
Muscle Weakness Other: Resistance exercise training Drug: Creatine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Creatine Supplementation on Muscle Mass and Function Among Older Women Subjected to Resistance Training
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

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Arm Intervention/treatment
Experimental: Creatine
Creatine 5 g/ day
Other: 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.

Drug: Creatine
Creatine powder 5 g day

Placebo Comparator: Placebo
Maltodextrin 5 g/day to be dissolved in water
Other: 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.




Primary Outcome Measures :
  1. Rectus Femoris Cross Sectional Height [ Time Frame: Twelve weeks ]
    Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound


Secondary Outcome Measures :
  1. Quadriceps Isometric Strength [ Time Frame: Twelve weeks ]
    Measurement of quadriceps isometric force using a quadriceps table

  2. Twelve Minutes Walk [ Time Frame: Twelve weeks ]
    Measurement of the distance that a participant can walk during 12 minutes


Other Outcome Measures:
  1. Serum Creatinine [ Time Frame: Twelve weeks ]
    Serum creatinine levels



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Absence of a significant disability, defined as the capacity to reach the health center by their own means with the use of any aid such as canes or wheelchairs
  2. Absence of disabling diseases such as cardiac, respiratory, liver or kidney failure or active cancer
  3. Absence of decompensated diabetes mellitus of hypertension. Diabetic patients with repeated fasting blood glucose levels below 120 mg/dl and a glycosylated hemoglobin below 7% will be allowed to participate. Hypertensive patients in treatment with a blood pressure (measured in at least two occasions) below 140/90 mm Hg will also be allowed.

Exclusion Criteria:

  1. Smoking or excessive consumption of alcohol
  2. Use of medications that can cause muscle dysfunction or limit exercise capacity such as adrenal steroids, chemotherapeutic agents, statins in high doses (ie more than 40 mg/day of atorvastatin) or muscle relaxants.
  3. Having a severe osteoarticular disease such as rheumatoid arthritis or severe osteoarthritis, with precludes participating in an exercise training program.
  4. Recent use of ergogenic supplements such as creatine.
  5. Being engaged in an active exercise training program.
  6. Being illiterate or having a level of cognitive dysfunction that precludes the free signature of a written informed consent to participate in the study.
  7. Any personal or socioeconomic condition that, in opinion of the research team, will hamper the correct compliance of the participant with the research program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188849


Locations
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Chile
INTA University of Chile
Santiago, Metropolitan, Chile, 7830489
Sponsors and Collaborators
University of Chile
Investigators
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Study Director: Sandra Hirsch, MD INTA University of Chile
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Responsible Party: Daniel Bunout, Medical Doctor, University of Chile
ClinicalTrials.gov Identifier: NCT02188849    
Other Study ID Numbers: Creatine elderly
Creatine INTA ( Other Identifier: INTA U de Chile )
First Posted: July 14, 2014    Key Record Dates
Results First Posted: October 30, 2015
Last Update Posted: October 30, 2015
Last Verified: October 2015
Keywords provided by Daniel Bunout, University of Chile:
creatine
resistance training
older women
muscle strength
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes