- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058654
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
March 22, 2018 updated by: GlaxoSmithKline
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)
This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomised, double-blind study of the effects of creatine supplementation on muscle energetics and cognitive function, using 31P-MRS and fMRI.
31P-MRS data will be acquired continuously during exercise phase and in the post-exercise metabolic recovery phase.
Participants will undergo a fMRI scan of the brain to record changes in the blood oxygen level dependent (BOLD) signal during a series of cognitive tests.
In addition, participants will undergo a resting state BOLD scan and a structural MRI scan for localization of brain regions.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, NW10 7EW
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Creatine Group
Whey protein (30 g) and creatine supplement (5 g) shaken with 250-300 ml water in a blender bottle, and the full shake to be taken twice a day for 14 days.
|
Creatine powder (5 g)
|
Placebo Comparator: Placebo Group
Whey protein (30 g) and bulking agent powder (5 g) shaken with 250-300 ml water in a blender bottle, and the full shake to be taken twice a day for 14 days.
|
Bulking agent powder (5 g)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCr Concentration (at rest)
Time Frame: Baseline to Day 3, 7 and 14
|
Change in PCr concentration (at rest), as measured by 31P- MRS on the calf.
Static MRS will be acquired at rest up to 2 min.
|
Baseline to Day 3, 7 and 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCr concentration during recovery
Time Frame: Baseline to Day 3, 7, and 14
|
Change in PCr concentration (during recovery) as measured by 31P- MRS on the calf.
Dynamic MRS will be acquired with the patient at rest for up to 20 min.
|
Baseline to Day 3, 7, and 14
|
Change in PCr from rest to recovery
Time Frame: Baseline to Day 3, 7, and 14
|
Change in PCr concentration (from rest to recovery) as measured by 31P- MRS on the calf.
|
Baseline to Day 3, 7, and 14
|
PCr recovery rate (PCr(T1/2))
Time Frame: Baseline to Day 3, 7 and 14
|
Measured by 31P-MRS on the leg
|
Baseline to Day 3, 7 and 14
|
ADP recovery rate (ADP (T1/2))
Time Frame: Baseline to Day 3, 7 and 14
|
Measured by 31P-MRS on the leg
|
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)
Time Frame: Baseline to Day 3, 7 and 14
|
Measured by 31P-MRS on the leg
|
Baseline to Day 3, 7 and 14
|
Lowest pH measured during pedal test or recovery (Minimum pH)
Time Frame: Baseline to Day 3, 7 and 14
|
Measured by 31P-MRS on the leg
|
Baseline to Day 3, 7 and 14
|
BOLD signal in the brain
Time Frame: Baseline to Day 14
|
Change in BOLD signal, as measured by an fMRI scan of the brain.
Data may be examined at both a whole-brain and region of interest (ROI) level, with ROIs defined either anatomically or based on clusters derived from the group data.
|
Baseline to Day 14
|
Cognitive function
Time Frame: Baseline to Day 14
|
A standard test battery will be used to examine changes in behavioural measures of cognition, including speed of processing (detection task), attention/vigilance (identification task), working memory, visual learning and memory, and reasoning and problem solving.
In addition, a visual analogue scales (VAS) will be used to assess subjective mood state.
|
Baseline to Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 24, 2014
Study Registration Dates
First Submitted
February 6, 2014
First Submitted That Met QC Criteria
February 6, 2014
First Posted (Estimate)
February 10, 2014
Study Record Updates
Last Update Posted (Actual)
March 23, 2018
Last Update Submitted That Met QC Criteria
March 22, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201131
- RH02061 (Other Identifier: GSK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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