The present study is a randomized controlled trial. Forty sedentary overweight women are included in the study.The participants are divided to two groups: control group (CG) and supplement group (SG). Both groups will receive healthy nutrition education, but SG will receive beta alanin supplement in tablets 6 gr/day divided in to times per day and CG will receive placebo tablets during 6 weeks.
In the beginning of the study and after 6 weeks, the anthropometric assessments and performance tests will be done. The anthropometric assessments include height, weight, body mass index, abdominal circumference and skin fold thickness. The body composition will be assessed with bio-impedance analyzer device. The performance test will be done on treadmill with ramp protocol till exhaustion of participants. The data in the beginning and end of the trail will be compared and analyzed in SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609077903N8
Registration date:2016-09-30, 1395/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-30, 1395/07/09
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
z_alizadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 6 Weeks Beta- alanine Supplementation on Exhaustion Time in Sedentary Overweight Women
Public title
The effect of Beta -alanin supplementation on exhaustion time
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Female sex; 20 to 45 years old; without pregnancy or regular physical activity or cigarette smoking; Without any diseases that affect the heart rate, diet or physical activity; without significant weight reduction over the past 6 months.
Exclusion criteria: Musculoskeletal problems; pregnancy; lack of desire to cooperation.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
The Center of Tehran University of Medical Sciences,Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-12-08, 1394/09/17
Ethics committee reference number
IR.TUMS.REC.1394.1367
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
(E65,E66)
ICD-10 code description
Obesity and other hyperalimentation
Primary outcomes
1
Description
Time to exhaustion
Timepoint
Befor and after
Method of measurement
Ramp test
Secondary outcomes
1
Description
Body composition change
Timepoint
Before and after
Method of measurement
bio-Impedance device
Intervention groups
1
Description
Beta alanin supplement, 6 gram per day, divided in 4 doses, 6 weeks
Category
Treatment - Drugs
2
Description
Placebo, four times per day, 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini Hospital
Full name of responsible person
Sara Hooshmand
Street address
Sports Medicine Department,Emam khomeini Hospital,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Moammaee Haajar
Street address
The Center of Tehran University of Medical Sciences,Ghods St., Keshavarz Blvd.
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,Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
No7, Ale-Ahmad Highway, Opposite of Shariati Hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
No7, Ale-Ahmad Highway, Opposite of Shariati Hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
No7, Ale-Ahmad Highway, Opposite of Shariati Hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)