Protocol summary
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Study aim
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Determining the effect of vitamin hydrogenated water consumption on blood and muscle parameters of professional athletes
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 45 professional athletes. Block random allocation with random allocation software is used for randomization.
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Settings and conduct
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This study in the field of nutrition and exercise is conducted on 45 professional athletes in Qazvin city. 45 athletes who will be included in the study through available sampling and those who meet the conditions of entry and satisfaction. The duration of the study is one week. At the beginning and end of the study, a blood sample will be taken from the athletes by the researcher and after the implementation of the Bruce protocol. Athletes will be divided into three groups of hydrogenated water, hydrogenated and supplemented water and control group through random allocation. The participants in the project and the evaluator researcher are unaware of the groups and how they are allocated. Bottles of water and similar supplements are used to blind the participants.
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Participants/Inclusion and exclusion criteria
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Criteria for entering the study:
Age group above 19 years
More than 2 years of continuous sports experience
3 training sessions per week, one hour each
No weight changes, no smoking and medicine
Criteria for not entering the study:
Reluctance to cooperate
Less than 2 years of sports experience
Lack of regular exercise
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Intervention groups
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Hydrogenated water group
Hydrogenated water and vitamin group
control group
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Main outcome variables
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Independent variables:
Main variables: malondialdehyde, superoxide dismutase, lactate dehydrogenase, total antioxidant capacity
General information
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Reason for update
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In the English title, the phrase " water on the blood and muscle parameters of professional athletes" is repeated twice
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240129060842N1
Registration date:
2024-02-28, 1402/12/09
Registration timing:
prospective
Last update:
2024-08-09, 1403/05/19
Update count:
1
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Registration date
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2024-02-28, 1402/12/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-03-05, 1402/12/15
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Expected recruitment end date
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2024-05-04, 1403/02/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of vitamin hydrogenated water on blood and muscle parameters of professional athletes
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Public title
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Investigating the effect of hydrogenated water on athletes
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Athletes must be in the age group above 19 years
Athletes who have more than 2 years of continuous sports experience
Sports activity at least three days a week and 60 minutes each session
Do not lose or gain weight during the last 4 months
Absence of physical and physiological damage
Absence of drug use, including all types of hormones, immune boosters and antioxidants, etc (at least three months before the research)
No smoking
Not using purified water at home
Willingness to cooperate in the project
Exclusion criteria:
Unwillingness to cooperate
Athletes who have less than 2 years of sports experience
Athletes who do not exercise regularly
Unwillingness to continue studying
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Age
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From 19 years old to 55 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, the randomization of the samples will be done using the random block allocation method. In this way, the number of 9 blocks was determined. In each block, three samples from group one, three samples from group two, and three samples from group three will be balanced. Blocking and determination of sequences will be done using random allocation software (Random Allocation Software version 1.0.0).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study will be conducted in a double-blind manner, so that the evaluator who collects the information (outcome evaluator) and the subjects are unaware of the type of intervention, considering the water bottles and similar supplements.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-12-11, 1402/09/20
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Ethics committee reference number
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IR.QUMS.REC.1402.259
Health conditions studied
1
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Description of health condition studied
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Professional athletes
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Malondialdehyde (MDA), lactate dehydrogenase (LDH), superoxide dismutase (SOD), total antioxidant capacity (TAC)
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Timepoint
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The beginning and end of the study
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Method of measurement
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Blood sampling
Secondary outcomes
1
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Description
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Weight, body composition
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Timepoint
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The beginning and end of the study
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Method of measurement
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Omron's scales
Intervention groups
1
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Description
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Intervention group: ntervention group: The first intervention group: hydrogenated water with vitamins - the intervention takes place for one week or four training sessions. In each session of the athletes of the intervention group of hydrogenated vitamin water, 500 cc of hydrogenated water with Alkaline Sticks from Diba Tejarat Middle East Company under the brand name Smart Life, in which one effervescent tablet of vitamin C (Eurho Vital) with a dose of 1000 dissolved and one capsule containing vitamin supplements They receive E with a dose of 400(Eurho Vital) and vitamin D(Eurho Vital) with a dose of 1000.
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Category
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Other
2
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Description
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Intervention group: Intervention group: The second intervention group: hydrogenated water - the intervention takes place for one week or four training sessions. In each session, the athletes of the hydrogenated water intervention group receive 500 cc of hydrogenated water with Alkaline Sticks of Diba Tejarat Middle East Company under the brand name Smart Life and one Plasio capsule.
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Category
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Other
3
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Description
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Control group: Control group: non-hydrogenated water with placebo - intervention is done for one week or four training sessions. In each session, the athletes of the control group receive 500 cc of drinking water and one Plasio capsule.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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80
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Investigating the effect of vitamin hydrogenated water consumption on blood and muscle parameter of professional athletes
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When the data will become available and for how long
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2023
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To whom data/document is available
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Scientific and academic researchers
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Under which criteria data/document could be used
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only Scientific and academic researchers
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From where data/document is obtainable
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Dr. Mohammad Reza Shiri Shahsawari
nutshiri@gmail.com
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What processes are involved for a request to access data/document
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by Email
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Comments
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