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

NCT02058654 | Completed Phase 1

• 2 other identifiers: 201131RH02061
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nutritional Status

Keywords

Creatine; Functional magnetic resonance imaging (fMRI); Phosphorus-31 magnetic resonance spectroscopy (31P-MRS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• PCr concentration during recovery

  Baseline to Day 3, 7, and 14

• Change in PCr from rest to recovery

  Baseline to Day 3, 7, and 14

• PCr recovery rate (PCr(T1/2))

  Baseline to Day 3, 7 and 14

• ADP recovery rate (ADP (T1/2))

  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)

  Baseline to Day 3, 7 and 14

Study Arms (2)

Creatine Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Creatine DRUG

Creatine powder (5 g)

Creatine Group

Placebo DRUG

Bulking agent powder (5 g)

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

Related Links

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

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 24, 2014
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

GB (1)