Protocol summary

Study aim
the effect of hydrogen-rich water consumption on serum malondialdehyde levels, total antioxidant capacity, blood pressure and rate pressure product during exhaustive exercise under induced hypoxia with a face mask in active young men.
Design
This research is an applied type with an experimental method; 18 to 32 years old active young men of Rasht city have been selected, will be performed voluntarily and randomly, counterbalance, cross over and double blind.
Settings and conduct
The test venue will be the Physiology Laboratory of Gilgun University; Before the research, the subjects will be informed about the purpose, benefits and possible risks of the experimental design in the familiarization session. The researcher and the participants will be blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria: Having perfect health Exclusion criteria: Lack of full health Body mass index above 25. catching a cold Taking any kind of medicine, including steroidal and non-steroidal anti-inflammatory drugs (aspirin family)
Intervention groups
Each subject will be in 4 different situations: 1. Mask with hydrogen rich water 2. Mask with placebo 3. hydrogen-rich water without mask 4. placebo without mask
Main outcome variables
effect of hydrogen-rich water consumption on serum levels of malondialdehyde; total antioxidant capacity; rate pressure product; Heart rate during exhaustive exercise under induced hypoxia with a face mask in active young men.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230304057606N1
Registration date: 2023-04-16, 1402/01/27
Registration timing: registered_while_recruiting

Last update: 2023-04-16, 1402/01/27
Update count: 0
Registration date
2023-04-16, 1402/01/27
Registrant information
Name
Soheila Khodadadikateshoori
Name of organization / entity
The University of guilan
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 6958
Email address
s_khodadadi_0@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hydrogen rich water consumption and exhaustive exercise activity under induced hypoxia conditions with facial mask on serum malondialdehyde level and total antioxidant capacity, blood pressure and rate pressure product in active young men.
Public title
Investigating the effect of hydrogen-rich water on active young men.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
People should be in perfect health. People who participate in the study will have normal blood pressure. Absence of any hormonal or inflammatory disease to affect blood pressure or antioxidant capacity. Absence of respiratory diseases due to the effect of the mask on the severity of the disease and heart rate during physical activity.
Exclusion criteria:
Subjects were excluded from the study if their mean systolic and/or diastolic blood pressure was equal to or greater than 140- and 90-mm Hg, respectively. Body mass index above 25 Hormonal diseases Inflammatory diseases respiratory diseases catching a cold Taking any medication, including steroidal and non-steroidal anti-inflammatory drugs (aspirin family), pharmaceutical and food supplements
Age
From 18 years old to 32 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is unaware of which people are in the intervention group and which are in the control group. The task of preparing hydrogen-rich water is the responsibility of the researcher, but he does not know which bottle will be given to which person. The participants know that he will consume hydrogen-rich water in the research, but he doesn't know that the water he consumes is normal mineral water or hydrogen rich water. (Alkaline sticks do not cause any color or taste changes in mineral water, so hydrogen-rich water and placebo look the same). The second person, as a research assistant, will control and implement this case based on a defined coding system.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Gillan University
Street address
km 6 of Tehran road
City
rasht
Province
Guilan
Postal code
4188693139
Approval date
2022-12-28, 1401/10/07
Ethics committee reference number
IR.GUILAN.REC.1401.088

Health conditions studied

1

Description of health condition studied
determination of serum malondialdehyde level; total antioxidant capacity; rate pressure product after consumption of hydrogen-rich water in active young men
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Malondialdehyde serum level and total antioxidant capacity after residual exercise after consumption of 3 servings of hydrogen-rich water
Timepoint
Blood sampling will be done ten minutes before the start of the physical activity and immediately after the end of the physical activity.
Method of measurement
Measurements will be done in the laboratory using the malondialdehyde and total antioxidant capacity assay kit.

Secondary outcomes

1

Description
Total antioxidant capacity serum level
Timepoint
Taking a blood sample ten minutes before starting physical activity and immediately after physical activity
Method of measurement
Using the measurement kit in the laboratory

Intervention groups

1

Description
We have two groups of 12 participants in the project, who are randomly divided into the intervention group and the control group. The first or intervention group consumes hydrogen-rich water. and 1.5 liters of water will be used in the form of half a liter before training, half a liter in the morning of the training day and half a liter 10 minutes before training.
Category
N/A

2

Description
The second group uses either placebo control or ordinary mineral water. The exercises and conditions of drinking mineral water will be the same as the intervention group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Physical Education and Sports Sciences, University of Gilan
Full name of responsible person
Soheila khodadadikateshoori
Street address
8 km of Tehran Road
City
Rasht
Province
Guilan
Postal code
4188693139
Phone
+98 13 3332 6958
Email
S_khodadadi_0@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of gilan
Full name of responsible person
جواد مهربانی
Street address
8 km of Tehran Road
City
Rasht
Province
Guilan
Postal code
4188693139
Phone
+98 13 3332 6958
Email
S_khodadadi_0@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of gilan
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
The university of Gillan
Full name of responsible person
Soheila Khodadadikateshoori
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.28, Shir Mohammadi Ave, Emam Blvd
City
Rasht
Province
Guilan
Postal code
4188693139
Phone
+98 13 3332 6958
Email
S_khodadadi_0@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of guilan
Full name of responsible person
Soheila Khodadadikateshoori
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 28 ,shirmohammadi Ave. ,Emamkhomaini Blvd.
City
Rasht
Province
Guilan
Postal code
4188693139
Phone
+98 13 3332 6958
Fax
Email
S_khodadadi_0@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of guilan
Full name of responsible person
Soheila Khodadadikateshoori
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 28 ,shirmohammadi Ave. ,Emamkhomaini Blvd.
City
Rasht
Province
Guilan
Postal code
4188693139
Phone
+98 13 3332 6958
Fax
Email
S_khodadadi_0@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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