1- Objectives: To evaluate the effect of Creatine on athletes mood and affect
2- Design: 44 male athletes in a body building club in Nahavand city.
3- Setting and conduct: the athletes were randomized to the study and placebo groups by using random numbers table.
4- Participants including major eligibility criteria: male athletes between 16-66 year old, without history of medical and psychiatric disorder or drug and alcohol consumption during past 3 months, were enrolled to the study.
5- Intervention: The study group received 5 gram Creatine daily for 6 months, and the placebo group received placebo (wheat flour) for the same time. Both groups completed 2 questionnaires (Beck depression scale and PANAS) in weeks 0, 3 and 6.
6- Main outcome measures: Athletes mood and affect
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040521609N1
Registration date:2015-06-27, 1394/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-27, 1394/04/06
Registrant information
Name
Aliehsan Abaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 3865
Email address
abaei.ah@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Iran university of medical sciences; Investigator
Expected recruitment start date
2013-12-12, 1392/09/21
Expected recruitment end date
2014-02-22, 1392/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Creatine adjunct effect on athletes mood and affect in body building clubs: a randomized clinical trial
Public title
The effect of Creatine adjunct on Athletes Mood and Affect.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: age between 16-60, male gender; regular daily physical exercise; not having history of allergy to Creatine; not having history of medical disease such as heart disease, renal disorder, thyroid disease or cancer; not having history of psychiatric drug consumption or OTC usage or drug and alcohol abuse during past 3 months; not having history of axis 1 psychiatric disorders.
Exclusion criteria: allergy to Creatine; any medical complication during the study.
Age
From 16 years old to 60 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The participants were randomized to the study and placebo groups by using random numbers table. Each participant received a random number and the researcher was not aware of each athlete's group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical science
Street address
keshavarz street, Ghods Ave., Tehran University
City
Tehran
Postal code
1417613151
Approval date
2013-09-22, 1392/06/31
Ethics committee reference number
130/1301/د/92
Health conditions studied
1
Description of health condition studied
Psychiatric conditions
ICD-10 code
F32
ICD-10 code description
Depression
Primary outcomes
1
Description
The score of mood
Timepoint
Before the intervention, 3 weeks after begining of intervention, 6 weeks after begining of intervention
Method of measurement
Beck depression scale
2
Description
The score of affect
Timepoint
Before the intervention, 3 weeks after begining of intervention, 6 weeks after begining of intervention
Method of measurement
PANAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the athletes were received 5 gram Creatine Monohydrate (from Karen pharmaceutical company) in 7 capsules, administered orally, daily for 6 weeks.
Category
Treatment - Drugs
2
Description
The placebo group received wheat flour capsule (7 capsules daily) for the same time (6 weeks) and the same appearance (Creatine capsule) in intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
YARAN body building club
Full name of responsible person
Amir Salehi
Street address
Before Miri St., Hafez Ave., Nahavand
City
Nahavand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Iran university of medical sciences
Full name of responsible person
Seyed Ali Javad Mousavi
Street address
Hemmat highway, Iran university of medical sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Iran university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Mehrdad Eftekhar
Position
Vice chancellor for research, Iran University of medical sciences, Medicine college
Other areas of specialty/work
Street address
Iran university of medical sciences, Near the Iran blood transfusion organization, Hemmat highway, Tehran
City
Tehran
Postal code
Phone
+98 21 6405 3312
Fax
Email
mehrdad.eftekhar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran institute of psychiatry
Full name of responsible person
Kaveh Alavi
Position
Assisstant professor
Other areas of specialty/work
Street address
Mansoori street, Tehran Institute of psychiatry, tehran
City
Tehran
Postal code
Phone
+98 21 6655 1515
Fax
Email
kavehalavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Aliehsan Abaei
Position
psychiatric resident
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8801 3865
Fax
Email
aliabaei2000@yahoo.com; abaei.ah@tak.iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)