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Creatine Supplementation on Cognition in Children

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ClinicalTrials.gov Identifier: NCT01803230
Recruitment Status : Unknown
Verified February 2013 by Bruno Gualano, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : March 4, 2013
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief Summary:
Creatine supplementation may improve cognitive function in elderly and vegetarian individuals. This study aims to investigate the role of creatine supplementation on cognitive function in healthy children.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: creatine supplementation Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Creatine Supplementation on Cognitive Function in Children
Study Start Date : February 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
placebo (dextrose)
Dietary Supplement: Placebo
Experimental: creatine
creatine supplementation
Dietary Supplement: creatine supplementation
creatine supplementation




Primary Outcome Measures :
  1. cognitive function [ Time Frame: 7 days ]
    assessed by a battery of cognitive tests as follows: colors and words attention test, controlled words association test, memory and figures learning, mental flexibility test and inhibitory control, digit span test, and intelligence quotient.


Secondary Outcome Measures :
  1. tissue creatine content [ Time Frame: 7 days ]
    as assessed by 1H-MRS.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy children
  • age between 10 to 12 years of age

Exclusion Criteria:

  • cognitive impairment
  • vegetarian diet
  • use of creatine in the past 6 months
  • chronic kidney disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803230


Contacts
Contact: Carlos Merege 551130913096 carlosmeregefilho@gmail.com

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, Brazil
Contact: Carlos Merege    5511 30913096    carlosmeregefilho@gmail.com   
Principal Investigator: Bruno Gualano, Professor         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Bruno Gualano, Professor University of Sao Paulo

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01803230     History of Changes
Other Study ID Numbers: Creatine in Children
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: February 2013

Keywords provided by Bruno Gualano, University of Sao Paulo:
children