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

Nutritional Status Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058654
• Other study ID #: 201131
• Secondary ID: RH02061
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2014
• Last updated: March 22, 2018
• Start date: December 1, 2013
• Est. completion date: June 24, 2014

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 24, 2014
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nutritional Status

Intervention

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

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCr Concentration (at rest)	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	PCr concentration during recovery	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
Secondary	Change in PCr from rest to recovery	Change in PCr concentration (from rest to recovery) as measured by 31P- MRS on the calf.	Baseline to Day 3, 7, and 14
Secondary	PCr recovery rate (PCr(T1/2))	Measured by 31P-MRS on the leg	Baseline to Day 3, 7 and 14
Secondary	ADP recovery rate (ADP (T1/2))	Measured by 31P-MRS on the leg	Baseline to Day 3, 7 and 14
Secondary	pH at the end of pedal test, or at the time of voluntary cessation (Post-pedal test pH)	Measured by 31P-MRS on the leg	Baseline to Day 3, 7 and 14
Secondary	Lowest pH measured during pedal test or recovery (Minimum pH)	Measured by 31P-MRS on the leg	Baseline to Day 3, 7 and 14
Secondary	BOLD signal in the brain	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
Secondary	Cognitive function	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

External Links

•   Results for Study 201131 can be found on the GSK Clinical Study Register.