The effect of Ѡ3 fatty acids supplementation on levels of PPARγ and UCP2 genes expression, serum level of UCP2 protein, metabolic status, and appetite in elite male athletes: a randomized control trial
The aim of the present study was to investigate the effect of 3-fatty acid supplementation on the expression levels of PPARγ and UCP2 genes, serum levels of UCP2 protein, metabolic status and appetite in elite male athletes.
Design
A randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
The study call will be distributed in Tabriz's clubs and sports centers and volunteer athletes will be enrolled.
Participants/Inclusion and exclusion criteria
36 athletes with a body mass index of 20 to 30 kg / m 2 will be included in the study. Criteria for excluding are receiving 3-fatty acid supplement in last month or chronic diseases and blood coagulation diseases.
Intervention groups
Supplement group will be given two milligrams of 1,000 mg daily of soft gel supplementation daily. In the placebo group, the soft gel similar to the supplement group, will be given by paraffin content.
Main outcome variables
Change in expression of PPARγ gene; UCP2 gene; UCP2 protein serum level; metabolic status; appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190625044008N1
Registration date:2019-12-19, 1398/09/28
Registration timing:registered_while_recruiting
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
sara moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3720 1222
Email address
saramoradi678@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ѡ3 fatty acids supplementation on levels of PPARγ and UCP2 genes expression, serum level of UCP2 protein, metabolic status, and appetite in elite male athletes: a randomized control trial
Public title
The effect of Ѡ3 fatty acids supplementation in elite male athletes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No history of chronic and/or blood coagulation diseases
Range of BMI of 18.5 to 25 kg / m 2
Willingness to participate in the study
Age 20– 30 years
Exclusion criteria:
Received Ѡ3 fatty acids supplements in last month
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
From among the volunteers to participate in the study, 36 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either fatty Acid Supplements Ѡ3 or placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main researchers (including students, tutors, and advisors) as well as the participants will be unaware of the type of supplement (fatty acid supplement 3 or placebo) received by each group. The person responsible for the packaging of supplements that is completely unrelated to the study will be required to assign a three-digit code to each package and keep the codes until the end of the study and analysis of the data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/1573113
Approval date
2019-10-30, 1398/08/08
Ethics committee reference number
IR.TBZMED.REC.1398.782
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anthropometric measures
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Calculation of body mass index (BMI) by dividing weight (Kg) by height squared (m2)
2
Description
Body composition
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Bioelectrical Impedance Analysis (BIA) to determine Fat mass (FM), Fat free mass (FFM), and Body water (BW)