Investigating the effect of drinking green tea on the total antioxidant capacity (TAC) of saliva in young smokers and non-smokers
Design
A clinical trial with a control group, with parallel groups, double-blind, with an accessible and non-random sampling method, the trial phase does not include divisions and on 40 people.
Settings and conduct
All participants were asked to consume a total of two cups of green tea per day for three weeks.Each cup is prepared by brewing 2 grams of green tea (one green tea bag) in 150 ml of hot water (80 degrees Celsius) for 3 minutes.Then, unstimulated saliva samples are collected once at the beginning of the study and once at the end of the intervention, and the TAC of the samples is measured in the laboratory with the FRAP test.
Venue: Birjand University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: the age of people should be between 20 and 27 years old and the population studied should be students of Birjand University of Medical Sciences.
Exclusion criteria: existence of systemic pulmonary diseases and use of medicine or vitamin supplements in the last 3 months
Intervention groups
20 healthy smoking volunteers and 20 healthy non-smoking volunteers are asked to consume two cups of green tea per day for three weeks. Then, unstimulated saliva samples are collected once at the beginning of the study and once at the end of the intervention, and the TAC value of the samples is measured in the laboratory with the FRAP test.
Main outcome variables
Total antioxidant capacity (TAC) of saliva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231230060572N1
Registration date:2024-05-14, 1403/02/25
Registration timing:registered_while_recruiting
Last update:2024-05-14, 1403/02/25
Update count:0
Registration date
2024-05-14, 1403/02/25
Registrant information
Name
Sajjad Shariati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1704
Email address
s.shariati10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of drinking green tea on the total antioxidant capacity (TAC) of saliva in young smokers and non smokers
Public title
Investigating the effect of drinking green tea on the total antioxidant capacity (TAC) of saliva in young smokers and non smokers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age of people should be between 20 and 27 years
The study population is students of Birjand University of Medical Sciences
Exclusion criteria:
Presence of systemic pulmonary diseases
Use of medicine or vitamin supplements in the last 3 months
Age
From 20 years old to 27 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention is designed in such a way that the people under study or the participants and the people who are responsible for evaluating and analyzing the data do not know about the allocation of the intervention groups and are kept blind.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Moalem Street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.BUMS.REC.1402.327
Health conditions studied
1
Description of health condition studied
Total antioxidant capacity of saliva
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total antioxidant capacity of saliva
Timepoint
Measuring the total antioxidant capacity of saliva at the beginning of the study (before the start of the intervention) and three weeks after drinking green tea
Method of measurement
Determination of the total antioxidant capacity of saliva in the laboratory by spectrophotometer in terms of micromol/liter
Secondary outcomes
empty
Intervention groups
1
Description
The first Intervention group: 20 healthy smoking volunteers were asked to consume a total of two cups of green tea per day for three weeks. Each cup is prepared by brewing 2 grams of green tea (one green tea bag) in 150 ml of hot water (80 degrees Celsius) for 3 minutes. Then, unstimulated saliva samples are collected once at the beginning of the study and once at the end of the intervention, and the TAC value of the samples is measured in the laboratory with the FRAP test.
Category
Prevention
2
Description
The second intervention group: 20 healthy non-smoking volunteers were asked to consume a total of two cups of green tea per day for three weeks. Each cup is prepared by brewing 2 grams of green tea (one green tea bag) in 150 ml of hot water (80 degrees Celsius) for 3 minutes. Then, unstimulated saliva samples are collected once at the beginning of the study and once at the end of the intervention, and the TAC value of the samples is measured in the laboratory with the FRAP test.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand University of Medical Sciences
Full name of responsible person
Sajjad Shariati
Street address
Birjand University of Medical Sciences, Moalem Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3238 1704
Email
s.shariati10@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mona Chahkandi
Street address
Birjand University of Medical Sciences, Moalem Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3238 1704
Email
Dentresearch@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?