Last updated: 11/03/2018 21:17:16
A clinical study to investigate the effects of creatine supplementation on muscle energetics and cognitive function in young healthy male athletes and an ageing population
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, double-blind, study to investigate the effects of creatine supplementation on muscle energetics and cognitive function in young healthy male athletes and an ageing population using phosphorus-31 magnetic resonance spectroscopy (31P MRS) and functional magnetic resonance imaging (fMRI)
Trial description: This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
PCr Concentration (at rest)
Timeframe: Baseline to Day 3, 7 and 14
Secondary outcomes:
PCr concentration during recovery
Timeframe: Baseline to Day 3, 7, and 14
Change in PCr from rest to recovery
Timeframe: Baseline to Day 3, 7, and 14
PCr recovery rate (PCr(T1/2))
Timeframe: Baseline to Day 3, 7 and 14
ADP recovery rate (ADP (T1/2))
Timeframe: Baseline to Day 3, 7 and 14
pH at the end of pedal test, or at the time of voluntary cessation (Post-pedal test pH)
Timeframe: Baseline to Day 3, 7 and 14
Lowest pH measured during pedal test or recovery (Minimum pH)
Timeframe: Baseline to Day 3, 7 and 14
BOLD signal in the brain
Timeframe: Baseline to Day 14
Cognitive function
Timeframe: Baseline to Day 14
Interventions:
Enrollment:
30
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Nutritional status
Product
GSK3129094
Collaborators
Not applicable
Study date(s)
December 2013 to June 2014
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
Yes
- Healthy volunteer: Group 1: male; Group 2: male or female.
- Aged 18–35 years (Group 1), or 50-70 years (Group 2).
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer’s participation in the trial or make it unnecessarily hazardous.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy volunteer: Group 1: male; Group 2: male or female.
- Aged 18–35 years (Group 1), or 50-70 years (Group 2).
- Dietary protein intake at or near the current recommended daily amount (0.75 to 0.85 g protein/kg/day).
- Participation in regular physical activity (aerobic and resistance training) 2–3 times a week for at least 6 months before the study starts (Group 1 only).
- Willingness to maintain a stable lifestyle throughout the study.
Exclusion criteria:
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer’s participation in the trial or make it unnecessarily hazardous.
- Impaired endocrine, thyroid, hepatic, respiratory, neurological, or renal function, diabetes mellitus, cardiovascular disease, coagulation disorder, autoimmune disease, phenylketonuria, hyperlipidaemia, or history of any psychotic mental illness.
- Any impairment affecting mobility and muscle metabolism of the lower limbs (such as arthritis).
- Surgery (eg stomach bypass) or medical condition that might affect absorption of supplements.
- Inability to complete the structured exercise program.
- Blood pressure and heart rate in seated position at the screening examination outside the ranges 90–140 mm Hg systolic, 40–90 mm Hg diastolic; heart rate 35-100 beats/min (Group 1) or 40-100 beats/min (Group 2).
- Metal implants that may affect the MRI scan, eg gold tooth or other metal dental devices (normal dental fillings are allowed), pacemaker, mechanical heart valve, replacement joint, shrapnel. If any metal in the body is identified, the investigators will make a decision, as to whether the subject should participate in the study.
- History of claustrophobia or subject feels unable to lie still on their back for a period of 90 mins in the MRI scanner, or subject unable to perform the required muscle exercise in the MRI scanner.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-24-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for Study 201131 can be found on the GSK Clinical Study Register.
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