Protocol summary

Study aim
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)

3

Description
Resting metabolic rate
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Indirect calorimetry

4

Description
Blood pressure
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Stethoscope

5

Description
Appetite status
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Visual analogue scale

6

Description
Serum UCP2 protein level
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
ELISA

7

Description
Uncoupling protein2 gene expression
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Real-time polymerase chain reaction (PCR)

8

Description
Peroxisome proliferator-activated receptors gamma gene expression
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Real-time polymerase chain reaction (PCR)

9

Description
Serum triglycerides
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Autoanalyzer kit

10

Description
Serum low density lipoprotein cholesterol
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Calculation of LDL-cholesterol by Friedewald equation

11

Description
Serum high density lipoprotein cholesterol
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Autoanalyzer kit

12

Description
Total cholesterol
Timepoint
Baseline and 3 weeks after intervention
Method of measurement
Autoanalyzer kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: soft gel supplement fatty acid Ѡ3 daily 2 soft gel, dose of 1 g with lunch and dinner for 3 weeks
Category
Treatment - Drugs

2

Description
Control group: soft gel placebo (paraffin) daily 2 soft gel, dose of 1 g with lunch and dinner for 3 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nutrition and Food Sciences
Full name of responsible person
Sara Moradi
Street address
Faculty of Nutrition and Food sciences, Tabriz University of Medical Sciences Attar Neishabouri St., Tabriz, I. R. Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
saramoradi678@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
nut-rc@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sara Moradi
Position
Ph.D. Student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Attar-e Nishaboori ST- Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 41 3441 5282
Email
saramoradi678@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Beit Allah Alipour
Position
Professor of Nutrition, in Faculty of Nutrition and Food Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar-e Nishaboori ST, Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 41 3335 7584
Email
alipourb@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sara Moradi
Position
Ph.D. Student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar neyshabori Ave., Golgash Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 83 3720 1222
Fax
Email
saramoradi678@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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