Protocol summary

Study aim
probiotic on body composition, GI,moods,performance
Design
Phase 3 double-blind parallel clinical trial, conducted on 36 unprofessional bodybuilders who are eligible to enter the study. athletes will be randomly divided into one of two groups receiving supplements and placebo. Probiotic supplement (Lactobacillus acidophilus, Lactobacillus paracasei and Lactobacillus plantarum) or placebo (2 billion colony forming units) is taken orally for 12 weeks by the subjects under study.
Settings and conduct
Participants are invited to participate in this project based on the call in social networks, sports clubs and sports medicine clinics.after the process of random allocation, people are divided into two groups receiving supplements and placebo. Intervention and control boxes with similar shape, smell, taste and packaging (labeled 1 and 2) are produced by Takgen zist Pharmaceutical Company, Tehran, Iran, which allows allocation concealment
Participants/Inclusion and exclusion criteria
Inclusion:20-40-year-old athletes with at least 3 months of bodybuilding experience - 6-10 hours of training per week Exclusion criteria: professional athletes,History of disease, participation in sports exercises other than bodybuilding
Intervention groups
Probiotic capsules containing Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei (2 billion colony forming units) and placebo like capsules were administered to athletes in the intervention and control groups, respectively, daily with a meal for 12 weeks.
Main outcome variables
Anthropometric measurements and profiles (weight, height, waist circumference, body mass index), body composition (fat mass and lean body mass), Gastro-intestinal symptoms, mood states, muscle strength and performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240424061562N1
Registration date: 2024-07-30, 1403/05/09
Registration timing: prospective

Last update: 2024-07-30, 1403/05/09
Update count: 0
Registration date
2024-07-30, 1403/05/09
Registrant information
Name
Nastaran Mahmoudi Shirkoohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5742
Email address
n-mahmoudish@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Assessment of the Effects of Probiotic Supplementation on Body Composition, Gastro-intestinal Symptoms, Moods and Performance in Unprofessional Athlete: A Randomized Clinical Trial
Public title
effects of probiotics in Unprofessional athletes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The satisfaction of the athlete Healthy male and female athletes between 20 and 40 years, who have an average of 6-10 hours of training per week (in this study, we defined a un-professional athlete as a person who trains between 6-10 hours per week but does not need to have a regular system and is at a lower level of competition, and the income of these people is not provided by sports A history of at least 3 months of bodybuilding training
Exclusion criteria:
Professional athletes with more than 10 hours of training per week pregnant and lactating premature menopause History of kidney, liver, nervous, autoimmune, pancreatitis, diabetes, cancer, thyroid, cardiovascular, pulmonary, gastric ulcer, anemia, food allergy, hypogonadism, inflammatory diseases based on the patient's statements and medical history Consumption of probiotics, for example dietary fibers such as inulin and galacto-oligosaccharides, regularly for 1 month before and during the study. alcohol consumption smoking (at least 5 cigarettes per day in the past 6 months) and other tobacco (pipes and hookahs at least once in the past month) Participating in other sports than bodybuilding Consumption of nutritional and sports supplements, at least 4-6 weeks before and throughout the intervention Following special diets People who participated in another study less than two months ago Taking antibiotics within 2 months or less from the start of the study Having acute gastrointestinal symptoms up to 2 months before the study Having digestive diseases and taking related drugs
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is done by Permuted Block Randomization method. In this method, eligible people who meet the inclusion criteria were selected and then randomly divided into two groups receiving probiotic supplement and placebo using 4 blocks based on gender (male and female). People in the intervention group take a probiotic supplement (probiotic cocktail including Lactobacillus acidophilus, Lactobacillus paracasei and Lactobacillus plantarum) with a dose of 2 x 109 (produced by the Tak Gen Zist Pharmaceutical Company) for 12 weeks.People in the control group also receive a placebo (containing maltodextrin) in the same package as a probiotic supplement. For the purpose of blinding, placebo and supplement are produced by Tekgen company and placed in the same packages. Then the packages are placed in paper boxes and received by the label company with a special code. Placebo and probiotic supplement codes remain with the company until the end of the study in order to blind researchers, and athlete.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the purpose of blinding, the placebo and the probiotic supplement are produced by Danesh Banyan Tekgen and are placed in exactly the same packages. Then, the packages are placed in paper boxes and received by the label company with a special code, and their distribution among the participants is done by a third person so that the researcher and the subjects will be unaware of the contents of the packages. The placebo and probiotic supplement codes remained with the company until the end of the study in order to blind the researchers and athletes. The placebo was identical to the probiotic supplement in terms of smell, taste, color, shape, size and packaging.
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
No. 44, Naderi st, keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-07-03, 1403/04/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.157

Health conditions studied

1

Description of health condition studied
Sport performance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Athletic anaerobic performance
Timepoint
Before and after supplementation
Method of measurement
Rast test (running-based anaerobic sprint test)

Secondary outcomes

1

Description
Muscle strength
Timepoint
before and after supplemenatation
Method of measurement
handgrip

2

Description
Anthropometric measurements
Timepoint
before and after supplementation
Method of measurement
Weight will be measured using a digital scale with minimal clothes and no shoes with an accuracy of 100 grams. The standing height of people will be measured using a standard height meter, without shoes and with an accuracy of half a centimeter. Waist circumference will be measured using a tape measure in the middle of the distance between the supra iliac bone and the last rib with an accuracy of 0.5 cm.

3

Description
Body composition
Timepoint
Before and after supplementation
Method of measurement
Using TANITA BC-418 bioimpedance analyzer

4

Description
Gastrointestinal symptoms
Timepoint
Before and after supplementation
Method of measurement
GASTROINTESTINAL SYMPTOM RATING SCALE questionnaire

5

Description
moods
Timepoint
Before and after supplementation
Method of measurement
Brunel Mood Scale questionnaire

Intervention groups

1

Description
Intervention group: Probiotic capsules containing Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei (2 billion colony-forming units) (produced by the Tak Gen Zist Pharmaceutical Company, Tehran, Iran) administered to athletes in the intervention daily with a meal for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: identical placebo capsules (maltodextrin) will be administered to athletes in the control groups daily with a meal for 12 weeks (produced by the Tak Gen Zist Pharmaceutical Company, Tehran, Iran)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Medicine Research Center, Tehran University of Medical Sciences
Full name of responsible person
Nastaran Mahmoudi Shirkoohi
Street address
N0. 7, Jalal-al-e-Ahmad Hwy, Tehran
City
Tehran
Province
Tehran
Postal code
1411734141
Phone
+98 21 8863 0227
Email
sportmed@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Keshavarz Blvd, Qods street
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nastaran Mahmoudi Shirkoohi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Naderi st, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5742
Email
Nastaran.mahmoudi7595@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kurosh Djafarian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Naderi st, keshavarz blv
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
002188955742
Email
Kdjafarian@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nastaran Mahmoudi Shirkoohi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Naderi st, keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
002188955742
Email
Nastaran.mahmoudi7595@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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 is potentially shareable after de-identifying individuals
When the data will become available and for how long
6 month after publication
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
According to the official request from the university or other legal authorities with the guarantee of intellectual property rights and data protection
From where data/document is obtainable
Nastaran mahmoudi 09381432063 Email:nastaran.mahmoudi7595@gmail.com
What processes are involved for a request to access data/document
‏Definition of needs: The requester must clearly define his needs, including the type of data or document needed, the desired format, and the purposes of use. 2- Contacting the source: the applicant must contact that source and announce his request. 3. Sending the request: The requester must send his request in an official and detailed manner, including the necessary information to identify and provide the desired data or document. 4. Receive and review: The applicant must review the received data or document and ensure that it meets their needs. 5. Feedback: If changes or further questions are needed, the requester should contact the source and provide feedback ‏In general, the time required to receive data or documents may vary depending on the complexity of the process, the type of source and the response speed of the source, but generally between 2-3 month
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