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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

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ClinicalTrials.gov Identifier: NCT02058654
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.

Condition or disease Intervention/treatment Phase
Nutritional Status Drug: Creatine Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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)
Actual Study Start Date : December 1, 2013
Actual Primary Completion Date : June 1, 2014
Actual Study Completion Date : June 24, 2014

Resource links provided by the National Library of Medicine


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.
Drug: Creatine
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.
Drug: Placebo
Bulking agent powder (5 g)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. PCr recovery rate (PCr(T1/2)) [ Time Frame: Baseline to Day 3, 7 and 14 ]
    Measured by 31P-MRS on the leg

  4. ADP recovery rate (ADP (T1/2)) [ Time Frame: Baseline to Day 3, 7 and 14 ]
    Measured by 31P-MRS on the leg

  5. 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

  6. 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

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02058654


Locations
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United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02058654    
Other Study ID Numbers: 201131
RH02061 ( Other Identifier: GSK )
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Keywords provided by GlaxoSmithKline:
Creatine
Functional magnetic resonance imaging (fMRI)
Phosphorus-31 magnetic resonance spectroscopy (31P-MRS)