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

NCT02188849 | Completed Phase 3 Results DMC

• 2 other identifiers: Creatine elderlyCreatine INTA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness

Keywords

creatine; resistance training; older women; muscle strength

Outcome Measures

Primary Outcomes (1)

• Rectus Femoris Cross Sectional Height

  Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound

  Twelve weeks

Secondary Outcomes (2)

• Quadriceps Isometric Strength

  Twelve weeks

• Twelve Minutes Walk

  Twelve weeks

Other Outcomes (1)

• Serum Creatinine

  Twelve weeks

Study Arms (2)

Creatine

EXPERIMENTAL

Creatine 5 g/ day

Other: Resistance exercise training; Drug: Creatine

Placebo

PLACEBO COMPARATOR

Maltodextrin 5 g/day to be dissolved in water

Other: Resistance exercise training

Interventions

Resistance exercise training OTHER

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; Placebo

Creatine DRUG

Creatine powder 5 g day

Creatine

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Absence of disabling diseases such as cardiac, respiratory, liver or kidney failure or active cancer
• 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.

You may not qualify if:

• Smoking or excessive consumption of alcohol
• 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.
• Having a severe osteoarticular disease such as rheumatoid arthritis or severe osteoarthritis, with precludes participating in an exercise training program.
• Recent use of ergogenic supplements such as creatine.
• Being engaged in an active exercise training program.
• Being illiterate or having a level of cognitive dysfunction that precludes the free signature of a written informed consent to participate in the study.
• Any personal or socioeconomic condition that, in opinion of the research team, will hamper the correct compliance of the participant with the research program.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

INTA University of Chile

Santiago, Metropolitan, 7830489, Chile

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Resistance Training; Creatine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Sandra Hirsch MD
• Organization: Institute of Nutrition and Food Technology University of Chile

shirsch@inta.uchile.cl

+56 229781485

Study Officials

• Sandra Hirsch, MD

  INTA University of Chile

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 30, 2015
• Results First Posted: October 30, 2015

Record last verified: 2015-10

Locations

CL (1)