Determining and comparing the acute effects of low and high doses of taurine supplementation on physical and cognitive functions of men aged 60-69 years
Design
This study has 2 groups, one group will use acetazolamide, and the other group will use a placebo. This research is one of the laboratory researches in which double-blind, randomized block studies will be performed using Random allocation software with intra-group design and mutual balance And has a clinical trial phase 3
Settings and conduct
This study will be conducted as a within-subject design(crossover), counterbalanced, and double-blind study in which the researcher and the subjects do not know who will take the supplement or placebo. First, the subjects will be divided into three groups, and one hour before the tests will take one gram, six grams, or placebo, and the same thing will be repeated by changing the groups for up to 3 weeks. This research will be conducted in Sanandaj.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Living in SanandajAge
range 60 to 69 years
BMI 18 to 24 (kg /m2)
Exclusion criteria:
Having any chronic disease
Take any supplement in the two months before the start of the study
Smoking
Intervention groups
Supplement group: The group will consume one gram of taurine.
Supplement group: The group will consume six grams of taurine.
Control group: the group that will take a placebo.
Main outcome variables
Balance، Muscular endurance، Cardiorespiratory endurance، Cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170326033146N7
Registration date:2022-01-26, 1400/11/06
Registration timing:prospective
Last update:2022-01-26, 1400/11/06
Update count:0
Registration date
2022-01-26, 1400/11/06
Registrant information
Name
Vahid Tadibi
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 9265
Email address
vahidtadibi@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acute effects of low and high doses of Taurine on physical and cognitive functions in 60-69 years old men
Public title
The effect of Taurine on cognitive and physical function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gender
Living in SanandajAge
range 60 to 69 years
BMI 18 to 24 (kg / m2)
Provide valid evidence of complete vaccination of COVID19 and at least three weeks after the second dose
Having the desired level of physical fitness to perform tests based on the Physical Activity Readiness Questionnaire (Q-PAR) and physician approval
Exclusion criteria:
Having any chronic disease
Take any supplement in the two months before the start of the study
Smoking
Age
From 60 years old to 69 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Someone other than the researchers will use the random allocation software for the allocation of the subjects by a randomized blocking method. During the process of allocation, each subject will be given a unique identification code that will be given to the main researchers together with the necessary treatment (Different doses of taurine or placebo).
The identification code will be used as a label to identify the group of each subject for data analysis after completion of the study. The random allocation software program can generate block randomization. The sample size and the name of the three groups (Different doses of taurine and placebo) will be defined in the randomization main menu of the software. Then, the block design will be entered as equal size. Also, the format of the unique identification code will be defined as alphanumeric with a fixed length. The last step is to generate the random list in which each entry in the list consists of a unique identification code and a group name.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because this study is double-blind, the subjects and researchers will not know who takes taurine or placebo, and someone else will assess the results. Also, in order not to detect different doses of taurine and placebo, they will be prepared in the same capsules and the placebo group will use maltodextrin powder.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah Razi University
Street address
Tagh-e-Bostan, University St.Razi University, Central Laboratory،Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Approval date
2022-01-12, 1400/10/22
Ethics committee reference number
IR.RAZI.REC.1400.088
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance
Timepoint
At the beginning of the study and after consuming one and six grams of taurine and a placebo
Method of measurement
Balance is measured using Timed up and go test - TUG
2
Description
Muscular endurance
Timepoint
At the beginning of the study and after consuming one and six grams of taurine and a placebo
Method of measurement
Muscular endurance is measured using the 30s chair stand test.
3
Description
Cardiorespiratory endurance
Timepoint
At the beginning of the study and after consuming one and six grams of taurine and a placebo
Method of measurement
Cardiorespiratory endurance is measured using a 6-min walk test
4
Description
Cognitive function
Timepoint
At the beginning of the study and after consuming one and six grams of taurine and a placebo
Method of measurement
Cognitive function is measured using the MMSE test.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests. One gram of taurine supplement will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move.
Category
Treatment - Drugs
2
Description
Intervention group 2: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests. Six grams of the taurine supplement will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move.
Category
Treatment - Drugs
3
Description
Control group: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests.1 g of maltodextrin will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi university
Full name of responsible person
Reza Nasimi
Street address
Razi University, Shahid Ashrafi Dormitory
City
Kermanshah
Province
Kermanshah
Postal code
46715-65981
Phone
+98 918 665 3141
Email
rezanasimiiiiiiii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzad Veisi
Street address
Deputy of Research and Technology, Razi University, University St., Tagh-e-Bostan,
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
veysi@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University
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
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Sciences, Razi University, University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Sciences, Razi University, University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Science, Razi University< University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Web page address
https://phe.razi.ac.ir/~vahidtadibi
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All Data
When the data will become available and for how long
assess ability immediately after the publication of the results
To whom data/document is available
Researchers
Under which criteria data/document could be used
For meta-analysis
From where data/document is obtainable
Vahid Tadibi vtadibi@yahoo.com
What processes are involved for a request to access data/document