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Creatine

Phase 1

Nutritional Status | Small molecule | Other |GSK plc|Last Updated: Mar 23, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Creatine · 1 trial · 1 indication

Phase 1 1
NCT02058654A Clinical Study to Investigate the Effects of Creatine Supplementation on Muscle Energetics and Cognitive Function in Young Healthy Male Athletes and an Ageing PopulationNutritional Status
COMPLETED30 Analytics
PHASE1COMPLETED
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 StatusUnlock trial analytics

Study Endpoints

Primary Endpoints

PCr Concentration (at rest)
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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Creatine GroupEXPERIMENTALWhey 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 GroupPLACEBO_COMPARATORWhey 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.

Interventions

NameTypeDescription
CreatineDRUGCreatine powder (5 g)
PlaceboDRUGBulking agent powder (5 g)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 an...

Countries:United Kingdom
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Frequently asked questions about Creatine

What is Creatine used for?

Creatine is being studied for its effects on nutritional status, specifically to investigate the effects of creatine supplementation on muscle energetics and cognitive function in young healthy male athletes and an ageing population. It is currently in Phase 1 clinical development as an investigational small molecule.

Who makes Creatine?

Creatine is being developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the supplement's effects on muscle energetics and cognitive function.

What phase is Creatine in?

Creatine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for its effects on nutritional status.

What clinical trials is Creatine in?

Creatine has one completed clinical trial registered as NCT02058654. This Phase 1 study investigated the effects of creatine supplementation on muscle energetics and cognitive function in young healthy male athletes and an ageing population. The trial enrolled 30 participants in the United Kingdom.

Is Creatine the same as creatine monohydrate?

Creatine is a small molecule supplement being studied for its effects on nutritional status. The clinical trial NCT02058654 evaluates creatine supplementation, which typically refers to creatine monohydrate, a common form used in dietary supplements. However, the specific form used in the trial is not detailed.