Creatine Supplementation and Cognitive and Physical Tests

NCT03352128 | Completed

• 1 other identifier: CREA
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Creatine Supplementation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Physical performance - reaction time (milliseconds) during a 7-min visuomotor reaction time task

  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.

Study Arms (2)

Creatine supplementation

EXPERIMENTAL

7-day creatine supplementation

Dietary Supplement: Creatine

Placebo supplementation

PLACEBO COMPARATOR

7-day calcium lactate supplementation

Dietary Supplement: Calcium lactate

Interventions

Creatine DIETARY_SUPPLEMENT

Participants will have to supplement themselves with creatine for 7 days (20g/day).

Creatine supplementation

Calcium lactate DIETARY_SUPPLEMENT

Participants will have to supplement themselves with calcium lactate for 7 days (elemental calcium: 0.780g/day).

Placebo supplementation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Human Physiology and Sports Physiotherapy Research Group

Brussels, Belgium

Location

MeSH Terms

Interventions

Creatine; calcium lactate

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 24, 2017
• Study Start: September 10, 2018
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)