1. Home
  2. Approved trials
  3. » فارسی

The effect of symbiotic supplementation on biochemical indicators of muscle damage, inflammation and nutritional status in professional futsal athletes

Protocol summary

Study aim
The aim of the present study is to determine the effect of synbiotic supplementation on the biochemical indicators of muscle damage, inflammation and nutritional status in professional futsal athletes.
Design
double blind randomized controlled trial, with parallel groups
Settings and conduct
The design of the study is a randomized, double-blind, placebo-controlled clinical trial. The number of 30 professional futsal athletes in the second league of the country will be included in the study after checking the entry and exit criteria. Synbiotic supplement capsules will be given to the intervention group and placebo containing starch daily for three months to the control group. Completing the demographic characteristics questionnaire at the beginning of the study, and completing the 3-day food recall questionnaires (including 2 normal days and 1 day off), physical activity questionnaire (IPAQ), anthropometric indices and body composition will be done at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
In this study, 30 male futsal players in the second division league of the country, aged 18-35, with at least 1 year of futsal sports experience and having at least 2-3 futsal training per week will be included in the study, but people who have intolerance and sensitivity to probiotics and similar products have or have specific muscle injuries and diseases, they will not be included in the study.
Intervention groups
The intervention and non-intervention groups will consume synbiotic supplements (probiotic + prebiotic) and placebo (containing starch) for three months, respectively.
Main outcome variables
biochemical indicators of muscle damage, inflammation and nutritional status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100123003140N23
Registration date: 2024-03-21, 1403/01/02
Registration timing: registered_while_recruiting

Last update: 2024-03-21, 1403/01/02
Update count: 0
Registration date
2024-03-21, 1403/01/02
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-26, 1402/12/07
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of symbiotic supplementation on biochemical indicators of muscle damage, inflammation and nutritional status in professional futsal athletes
Public title
Investigating the effect of synbiotics in professional futsal athletes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender Not having specific diseases such as autoimmune diseases, metabolic disorders and infectious and inflammatory diseases People with at least 1 year of futsal sports experience Having at least 2-3 futsal practice per week Being a permanent member of the team and registering one's profile in the national league. Declare agreement to participate in the plan and complete the plan's informed consent
Exclusion criteria:
Intolerance and sensitivity to synbiotics and similar products Taking antibiotics, painkillers, acute and chronic illness, acute and chronic illness medications or other medications in the last month Using drugs that affect lipid metabolism, such as cholesterol-lowering drugs, estrogen, progesterone, diuretics, niacin, tricyclic antidepressants, antiepileptic drugs (phenytoin, valproic acid, carbamazepine, and phenobarbital) and taking drugs that affect appetite and weight. Body, medicine to control blood sugar having specific muscle injuries and diseases such as myopathies (muscular dystrophy diseases); Neuropathies (Charcot-Marie-Tooth disease), nerve and muscle junction diseases (congenital myasthenia syndrome), motor neuron diseases (spinal muscular atrophy), fibromyalgia, myasthenia gravis before starting the study.
Age
From 18 years old to 35 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be grouped into two intervention groups (receiver of synbiotic supplement) and control group (receiver of placebo) by random block method and 1:1 allocation ratio. In order to conceal the allocation (Concealment Allocation), the allocation sequence was determined by a person not involved in the study and in a blinded manner using Randomizer (https://www.randomizer.org/) and the drugs and placebo were also in identical boxes on the back. They will be numbered together from 1 to 30. For the intervention group, Familact synbiotic supplement capsule and for the control group, placebo containing starch will be given daily for three months, and this drug delivery will be blinded and will be done by another person. Therefore, the participants, the person allocating the participants in the groups, the person delivering the supplement and placebo and the data collector, will be blinded and unaware of the type of capsules received by each participant.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, neither the researcher nor the participants will know whether each person will be in the intervention group or the control group. For blinding, synbiotic and placebo pills will be similar in appearance, packaging and labeling. Packaging and coding of the capsules will be done by the manufacturer.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2024-02-19, 1402/11/30
Ethics committee reference number
IR.TBZMED.REC.1402.887

Health conditions studied

1

Description of health condition studied
Muscle damage
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum creatine kinase levels
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

2

Description
Serum lactate dehydrogenase levels
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

3

Description
Serum troponin levels
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

4

Description
Serum aspartate aminotransferase levels
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

5

Description
Serum levels of IL-6
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

6

Description
Serum levels of hsCRP
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

7

Description
Serum levels of TNF-α
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

8

Description
Anthropometric indices
Timepoint
Before and after the intervention
Method of measurement
Scale, Stadiometer,Tape

9

Description
Body composition indices
Timepoint
Before and after the intervention
Method of measurement
Impedance bio-electric system

10

Description
Dietary intake
Timepoint
Before and after the intervention
Method of measurement
Three-day food recall questionnaire

Secondary outcomes

1

Description
Blood levels of fasting glucose
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

2

Description
Blood levels of fasting insulin
Timepoint
Before and after the intervention
Method of measurement
ELIZA KIT

3

Description
Serum levels of HbA1c
Timepoint
Before and after the intervention
Method of measurement
Spectrophotometry

4

Description
Blood levels of triglycerides
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

5

Description
Blood levels of total cholestrol
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

6

Description
Blood levels of HDL-cholesterol
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method

7

Description
Blood levels of LDL-cholestrol
Timepoint
Before and after the intervention
Method of measurement
Friedewald formula

Intervention groups

1

Description
Intervention group: Femilact synbiotic product (probiotic + prebiotic) with 30 oral capsules, gluten-free, containing a mixture of probiotic strains: Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium lactis , Streptococcus thermophilus, Fructooligosaccharides (FOS) with a combined amount of 109 CFU and Fructooligosaccharides (FOS) (as a prebiotic) will be used daily for 3 months.
Category
Other

2

Description
Control group: Control group: a daily placebo tablet in the form of a capsule containing starch and the contents of inactive substances are completely similar to the synbiotic capsule in terms of color and weight. It will also be prepared by Danesh Banyan Bio Fermentation Pharmaceutical Company and will be given for 3 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Jiroft City Football Board
Full name of responsible person
Mahdi Azami
Street address
Sports and Youth Department of Jiroft city, Zahmatkeshan Stadium, Imam Khomeini Blvd., Jiroft, Iran.
City
Jiroft
Province
Kerman
Postal code
7861611111
Phone
+98 34 4335 3292
Email
Jiroftfootball@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Tabriz University of Medical Sciences, Golbad Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Web page address
https://researchvice.tbzmed.ac.ir/page/5/%D9%85%D8%B9%D8%A7%D9%88%D9%86-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C.html
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Bahram Pourghassem Gargari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neishaboori St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1435 7580
Fax
+98 41 1334 0634
Email
pourghassemb@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghassem Gargari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neishaboori St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1435 7580
Fax
+98 41 1334 0634
Email
pourghassemb@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghassem Gargari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neishaboori St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1435 7580
Fax
+98 41 1334 0634
Email
pourghassemb@tbzmed.ac.ir

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
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
Title and more details about the data/document
All data
When the data will become available and for how long
After completing the study and publishing the articles
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
With the permission of the researcher and sponsor of the project
From where data/document is obtainable
Project researchers
What processes are involved for a request to access data/document
email or phone call
Comments
Loading...