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The effect of policosanol supplementation on glycemic status, lipid profile, oxidative stress, anthropometric variables, and athletic performance in male taekwondo athletes

Protocol summary

Study aim
Investigating the effect of policosanol supplementation on sugar parameters, lipid parameters, oxidative stress, anthropometric indices and sports performance in male taekwondo athletes.
Design
Clinical trials phase 2, two parallel groups, double-blind, randomized.
Settings and conduct
Two control and treatment groups are used. It will be done in the Paramedical School of Jundishapur University of Medical Sciences, Ahvaz. Researchers and participants are blinded in two ways
Participants/Inclusion and exclusion criteria
People over 18 years old Male gender Willingness to cooperate Having a BMI between 18.5 and 29.9 Having at least three times a week for an hour of training each time Having at least one year of experience in Taekwondo
Intervention groups
Treatment group: Receiving policosanol 25mg daily. Control group: receiving placebo.
Main outcome variables
Changes in biochemical factors (triglyceride, cholesterol, plasma atherogenic index, total antioxidant capacity, malondialdehyde, fasting blood sugar, fasting insulin level, weight, body mass index, waist circumference, hip circumference) and sports performance (aerobic and anaerobic)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190731044392N3
Registration date: 2024-05-23, 1403/03/03
Registration timing: prospective

Last update: 2024-05-23, 1403/03/03
Update count: 0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Hamidreza Razmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3615 7946
Email address
hamidrezarazmi95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2025-02-08, 1403/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of policosanol supplementation on glycemic status, lipid profile, oxidative stress, anthropometric variables, and athletic performance in male taekwondo athletes
Public title
The effect of polycosanol supplementation on male taekwondo athletes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old Male gender Willingness to cooperate Having a BMI between 18.5 and 29.9 Having at least three times a week for an hour of training each time Having at least one year of experience in Taekwondo
Exclusion criteria:
Unwillingness to participate in the study Suffering from metabolic diseases Presence of kidney diseases (acute or chronic kidney failure, etc.) and diagnosed bone diseases Smoking (cigarettes, hookah, drugs, etc.) Use of any supplements at the start of the study or 3 months before Following a special diet during the study Follow a specific practice while studying
Age
From 18 years old to 60 years old
Gender
Male
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a simple randomized clinical trial on subjects with fatty liver. In this study, individuals are divided into two groups of drugs and placebo. The method of assigning subjects to each group is that individuals are assigned every other one.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, the participants are explained about the study. This study is a double blind study. The two drug and placebo groups are given completely similar capsules and they do not know the contents of the capsules. The researcher does not know about the groups and someone outside the study codes the capsules randomly.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical sciences
Street address
Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165777696
Approval date
2024-05-18, 1403/02/29
Ethics committee reference number
IR.AJUMS.REC.1403.053

Health conditions studied

1

Description of health condition studied
not applicable
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Total antioxidant capacity
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

2

Description
Malondialdehyde
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

3

Description
Glutathione Peroxidase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

4

Description
Superoxide dismutase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

5

Description
Waist circumference
Timepoint
Before intervention and 3 months after intervention
Method of measurement
By measuring tape according to meter

6

Description
Hip circumference
Timepoint
Before intervention and 3 months after intervention
Method of measurement
By measuring tape according to meter

7

Description
Weight
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Digital scale

8

Description
Body mass index
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Body weight in kilograms divided by height squared in meters

9

Description
Total cholestrol
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

10

Description
Low-density lipoprotein
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

11

Description
high-density lipoprotein
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

12

Description
Triglyciride
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

13

Description
Fasting blood sugar
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

14

Description
Insulin
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Blood test

15

Description
Aerobic performance
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Bruce protocol

16

Description
Anaerobic performance
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Wingate Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: daily consumption of policosanol supplement 25 mg orally for three months, with lunch
Category
Other

2

Description
Control group: recipient of a 1 gram placebo capsule made in Jundishapur Faculty of Pharmacy, Ahvaz (containing cellulose, silicon dioxide and starch) for 90 days, orally with lunch
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Takhti Stadium and Sports Complex
Full name of responsible person
Hamidreza Razmi
Street address
Ahwaz, Amanie, Ahvaz Takhti Stadium and Sports Complex
City
Ahvaz
Province
Khouzestan
Postal code
6165777696
Phone
+98 61 3333 3050
Email
hamidrezarazmi95@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehrnoosh Zakerkish
Street address
Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165777696
Phone
+98 61 3333 3050
Email
zakerkishm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hamidreza Razmi
Position
PhD Student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz jundishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165777696
Phone
+98 61 3333 3050
Email
Hamidrezarazmi95@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Bijan Helli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165777696
Phone
+98 61 3333 3050
Email
helli-b@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
حميدرضا رزمي
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165777696
Phone
+98 61 3333 3050
Email
hamidrezarazmi95@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after the participants in the study are unrecognizable
When the data will become available and for how long
The data access period after printing the article.
To whom data/document is available
The data in this study will be available to researchers working at academic and scientific institute.
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher.
From where data/document is obtainable
Hamidreza Razmi
What processes are involved for a request to access data/document
The researcher or pharmaceutical company can send their request to the email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.
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