Nutritional StatusPhase 1NCT02058654
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
A Phase 1 study testing Creatine in people with Nutritional Status, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status
- What is being tested?
- Creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2013to 24 Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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)
This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.
Read the 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.
- Conditions
- Nutritional Status
- Being tested
- Creatine, Placebo
- Keywords
- Creatine, Functional magnetic resonance imaging (fMRI), Phosphorus-31 magnetic resonance spectroscopy (31P-MRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDrug
Creatine powder (5 g)
PlaceboDrug
Bulking agent powder (5 g)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 3, 7 and 14
Secondary outcomes (8)
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.
Measured: Baseline to Day 3, 7, and 14
Change in PCr from rest to recovery
Change in PCr concentration (from rest to recovery) as measured by 31P- MRS on the calf.
Measured: Baseline to Day 3, 7, and 14
PCr recovery rate (PCr(T1/2))
Measured by 31P-MRS on the leg
Measured: Baseline to Day 3, 7 and 14
ADP recovery rate (ADP (T1/2))
Measured by 31P-MRS on the leg
Measured: 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)
Measured by 31P-MRS on the leg
Measured: Baseline to Day 3, 7 and 14
Lowest pH measured during pedal test or recovery (Minimum pH)
Measured by 31P-MRS on the leg
Measured: Baseline to Day 3, 7 and 14
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.
Measured: Baseline to Day 14
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.
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study start1 Dec 2013
- Primary completion1 Jun 2014
- Study completion24 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058654
- Sponsor's protocol ID
- 201131
- Other IDs
- RH02061
- Status last verified
- Mar 2018
- First submitted
- 6 Feb 2014
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02058654
- Acronym / sponsor ID
- 201131
- Conditions
- Nutritional Status
- Keywords
- Creatine, Functional magnetic resonance imaging (fMRI), Phosphorus-31 magnetic resonance spectroscopy (31P-MRS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 24 Jun 2014 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine Group | Experimental | Drug: CreatineWhey 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. |
| Placebo Group | Placebo comparator | Drug: PlaceboWhey 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineCreatine powder (5 g) | Drug | Creatine Group |
| PlaceboBulking agent powder (5 g) | Drug | Placebo Group |
Primary outcome
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.
8 secondary outcomes
PCr concentration during recovery
Time frame: Baseline to Day 3, 7, and 14
Change in PCr from rest to recovery
Time frame: Baseline to Day 3, 7, and 14
PCr recovery rate (PCr(T1/2))
Time frame: Baseline to Day 3, 7 and 14
ADP recovery rate (ADP (T1/2))
Time frame: 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
Lowest pH measured during pedal test or recovery (Minimum pH)
Time frame: Baseline to Day 3, 7 and 14
BOLD signal in the brain
Time frame: Baseline to Day 14
Cognitive function
Time frame: Baseline to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Results for Study 201131 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Creatine in people with Nutritional Status, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCr Concentration (at rest) (time frame: Baseline to Day 3, 7 and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.