Clinical trial of the effect of Camellia sinensis L. and Melissa officinalis L. infusion on oxidative stress biomarkers (total antioxidant capacity, catalase and malondialdehyde) in welders
Both of Camellia sinensis and Melissa officinalis have antioxidant effects but it is still not clear which is more effective. This study is a crossover randomized clinical trial on 20-50 years old individuals with one year welding history. They are randomly assigned into two groups, green tea (10 men) and Melissa officinalis (10 men), based on random numbers table. Participants receive green tea or Melissa officinalis as infusion 2 times a day, 2 gram each time for 4 weeks. After three weeks of washout, intervention of groups moved. Demographic information, dietary intake, anthropometric, physical activity, and oxidative stress markers (Malondialdehyde, Catalase, Total antioxidant capacity) are measured before and after of each intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015103110826N18
Registration date:2017-02-23, 1395/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-23, 1395/12/05
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences of Yazd
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of Camellia sinensis L. and Melissa officinalis L. infusion on oxidative stress biomarkers (total antioxidant capacity, catalase and malondialdehyde) in welders
Public title
Survey of the effect of Camellia sinensis L. and Melissa officinalis L. infusion on oxidative stress biomarkers in welders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: residing in Yazd; age between 20-50 years; welding as the main job with at least one year exposure; without chronic diseases such as hypertension, heart failure, cancer, thyroid disorders, asthma, diabetes and anemia diagnosed by a physician based on self-declarations; do not drug use; do not use alcohol and without regular intake of herbal infusions. Excluding criteria: Taking antioxidant or vitamins supplements during study; radiation therapy during study; consume less than 80% packet tea; loss to follow-up or immigration.
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
compare the antioxidant effects of Camellia sinensis and Melissa officinalis is done for the first time
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences of Yazd
Street address
Alem Square, Shohadaye Gomnam Blvd, University of Medical Sciences
City
Yazd
Postal code
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.SSU.SPH.REC.1394.25
Health conditions studied
1
Description of health condition studied
Occupational exposure
ICD-10 code
Z57.5
ICD-10 code description
Occupational exposure to toxic agents in other industries Solids, liquids, gases or vapours
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
Before and after of each intervention
Method of measurement
Reduction 1,1-diphenyl-2-picrylhydrazyl
2
Description
Malondialdehyde
Timepoint
Before and after of each intervention
Method of measurement
Colorimetry
3
Description
catalase
Timepoint
Before and after of each intervention
Method of measurement
Sectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 consume 4 grams brewed lemon balm and twice a day for 4 weeks, then after 3 weeks wash out; consume 4 grams brewed green tea twice a day for 4 weeks
Category
Other
2
Description
Group 2 brewed 4 grams green tea and consumed twice a day for 4 weeks, then after 2 weeks wash out; brewed 4 grams Melissa officinalis and consumed twice a day for 4 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Industrial centers with welders
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services of Yazd
Full name of responsible person
Amirhoushang Mehrparvar
Street address
Alem Square- Shohadaye Gomnam Blvd- The campus of University of Medical Sciences
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences and Health Services of Yazd
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
fatemeh jafari
Position
Msc student, Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Postal code
Phone
+98 35 3820 9100
Fax
Email
fatemejafari70@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahid Sadoughi University of Medical Sciences
Full name of responsible person
Azadeh Najarzadeh
Position
PhD in Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Postal code
Phone
+98 35 3820 9100
Fax
Email
azadehnajarzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
fatemeh jafari
Position
Msc student, Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Postal code
Phone
00
Fax
Email
fatemejafari70@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)