Creatine Supplementation and Cognitive and Physical Tests (CREA)

The Effect of Creatine Supplementation on Cognitive and Physical Tests

To assess whether brain creatine availability has an effect on cognition. To do so we will seek to increase brain creatine concentration via a creatine supplementation protocol.

Study Overview

• Status: Completed
• Conditions: Healthy; Creatine Supplementation
• Intervention / Treatment: Dietary supplement: Creatine; Dietary supplement: Calcium lactate

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Human Physiology and Sports Physiotherapy Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy (No neurological illness including cardiovascular, renal, and endocrine disorder)
• Male/female
• No medication / supplements
• Non-smoker
• Low to moderately active
• Between 18 and 35 years old

Exclusion Criteria:

• Injuries
• Illness
• Use of medication
• Use of creatine in the last 3 months
• History of head trauma or seizure
• Vegetarian diet [24]
• Not being able to follow up the restrictions and prohibitions for the subjects (see Restrictions and prohibitions for the subjects)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine supplementation; 7-day creatine supplementation	Dietary supplement: Creatine; Participants will have to supplement themselves with creatine for 7 days (20g/day).
Placebo Comparator: Placebo supplementation; 7-day calcium lactate supplementation	Dietary supplement: Calcium lactate; Participants will have to supplement themselves with calcium lactate for 7 days (elemental calcium: 0.780g/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance - change in accuracy (%) during a 90-min cognitive task (i.e. Stroop task)	Accuracy (in %) will be assessed during a cognitive task, this cognitive task will be completed after both 7-day supplementation protocols (i.e. placebo and creatine)	During both lab visits (i.e. after both 7-day supplementation protocols); Accuracy (%) will be assessed during both lab visits with a 90-min cognitive task; Accuracy during the 90-min task will be reported as mean accuracy during 8 blocks of 11min15sec
Cognitive performance - change in reaction time (milliseconds) during a 90-min cognitive task (i.e. Stroop task)	Reaction time (in milliseconds) will be assessed during a cognitive task, this cognitive task will be completed after both 7-day supplementation protocols (i.e. placebo and creatine)	During both lab visits (i.e. after both 7-day supplementation protocols); Reaction time (RT) will be assessed during both lab visits with a 90-min cognitive task; RT during the 90-min task will be reported as mean RT during 8 blocks of 11min15sec

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical performance - reaction time (milliseconds) during a 7-min visuomotor reaction time task	Reaction time (in milliseconds) will be assessed during a visuomotor reaction time task, this physical task will be completed after both 7-day supplementation protocols (i.e. placebo and creatine)	During both lab visits (i.e. after both 7-day supplementation protocols); visuomotor reaction time will be assessed during both lab visits with a 7-min visuomotor reaction time task.

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: CREA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No