Trial Outcomes & Findings for Effects of Creatine Supplementation on Muscle Mass and Function Among Older Women Subjected to Resistance Training (NCT NCT02188849)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Twelve weeks

Results posted on

2015-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Creatine 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	Placebo 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 Study STARTED	25	25
Overall Study COMPLETED	22	17
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Creatine 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	Placebo 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 Study Lost to Follow-up	3	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Creatine n=25 Participants 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	Placebo n=25 Participants 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 n=50 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 4.5 • n=5 Participants	68.1 years STANDARD_DEVIATION 4.9 • n=7 Participants	67.8 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Chile	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Twelve weeks

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

Outcome measures

Outcome measures
Measure	Creatine n=22 Participants 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	Placebo n=17 Participants 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.
Rectus Femoris Cross Sectional Height	17.5 cm Standard Deviation 2.0	17.6 cm Standard Deviation 2.8

SECONDARY outcome

Timeframe: Twelve weeks

Measurement of quadriceps isometric force using a quadriceps table

Outcome measures

Outcome measures
Measure	Creatine n=22 Participants 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	Placebo n=17 Participants 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.
Quadriceps Isometric Strength	278.6 Newtons Standard Deviation 53.9	225.3 Newtons Standard Deviation 50.6

SECONDARY outcome

Timeframe: Twelve weeks

Measurement of the distance that a participant can walk during 12 minutes

Outcome measures

Outcome measures
Measure	Creatine n=22 Participants 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	Placebo n=17 Participants 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.
Twelve Minutes Walk	1091.4 meters Standard Deviation 101.1	1087.5 meters Standard Deviation 108

OTHER_PRE_SPECIFIED outcome

Timeframe: Twelve weeks

Serum creatinine levels

Outcome measures

Outcome measures
Measure	Creatine n=22 Participants 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	Placebo n=17 Participants 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.
Serum Creatinine	0.8 mg/dl Standard Deviation 0.12	0.75 mg/dl Standard Deviation 0.13

Adverse Events

Creatine

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Creatine n=22 participants at risk；n=25 participants at risk 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	Placebo n=17 participants at risk；n=25 participants at risk 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.
Injury, poisoning and procedural complications Falls	13.6% 3/22 • Number of events 3 • 12 weeks	5.9% 1/17 • Number of events 1 • 12 weeks
Gastrointestinal disorders Gastroinftestinal symptoms	13.6% 3/22 • Number of events 4 • 12 weeks	11.8% 2/17 • Number of events 3 • 12 weeks
Musculoskeletal and connective tissue disorders Pain	18.2% 4/22 • Number of events 5 • 12 weeks	29.4% 5/17 • Number of events 6 • 12 weeks
Infections and infestations Fever	4.5% 1/22 • Number of events 1 • 12 weeks	0.00% 0/17 • 12 weeks

Additional Information

Sandra Hirsch MD

Institute of Nutrition and Food Technology University of Chile

Phone: +56 229781485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place