Effect of oral administration of green tea on DPPH free radical scavenging , level of zinc, iron and copper in the serum of patients with Alzheimer's disease
The aim of this study is to investigate the serum levels of trace elements zinc, copper, iron and 2,2-Diphenyil-picrylhydrazyl (DPPH ∙) radical scavenging power in Alzheimer's patients before and after green tea consumption. Alzheimer's disease (AD), is the most prevalent degenerative disorder of the brain, among elderly individuals. Many studies indicate that zinc, copper and iron participate in redox reactions, by producing the hydroxyl radicals. It has been suggested that green tea is a strong metals chelator that can remove reactive oxygen species in the hippocampus of the brain. This prospective interventional study will conduct on 30 patients with AD. The diagnostic criteria is National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria, with the Mini-Mental State Examination ≤10 (MMSE) and age ≥65. Inflammatory and infectious diseases, vitamins and folic acid supplementation are the exclusion criteria. Patients will swallow four green tea tablets per day for two months (2g per day in 2 divided doses). DPPH radical level and levels of trace elements will determine before and after dietary intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612063684N8
Registration date:2017-08-16, 1396/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Soleiman Mahjoub
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0569
Email address
s.mahjoub@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for research of Babol University of Medical Sciences
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2017-10-12, 1396/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral administration of green tea on DPPH free radical scavenging , level of zinc, iron and copper in the serum of patients with Alzheimer's disease
Public title
The effect of taking green tea on patients with Alzheimer's
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Mini-mental state examination score between 0-10; rejection of other causes of dementia by performing MRI, CT scans and laboratory tests (TSH, T3, T4, CBC / DIFF, BUN / CR, FBS, LFT and ESR) .
exclusion criteria: green tea allergy; inflammatory and infectious diseases such as hepatitis, anemia, and diabetes; treated with antioxidant agents such as vitamin E, C, A and folic.
Age
From 65 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran ,Iran
City
Babol
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2013-09-06, 1392/06/15
Ethics committee reference number
3609
Health conditions studied
1
Description of health condition studied
Alzheimer
ICD-10 code
G30.1
ICD-10 code description
Alzheimer disease with late onset
Primary outcomes
1
Description
DPPH free radical level
Timepoint
Before the intervention and two months after the end of the intervention
Method of measurement
according to percent by using the Brand-Williams method
2
Description
trace elements zinc
Timepoint
Before the intervention and two months after the end of the intervention
Method of measurement
In micrograms per deciliter using colorimetric method
3
Description
trace elements iron
Timepoint
Before the intervention and two months after the end of the intervention
Method of measurement
In micrograms per deciliter using colorimetric method
4
Description
trace elements copper
Timepoint
Before the intervention and two months after the end of the intervention
Method of measurement
In micrograms per deciliter using colorimetric method
Secondary outcomes
empty
Intervention groups
1
Description
Patients will take 1 gr oral green tea tablet twice a day (2 gr per day in 2 divided doses) for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehravaran
Full name of responsible person
Dr. Mehdi Moghadasi
Street address
Mehravaran-Shomal nursing home, Kayasar Road
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Soleiman Mahjoub
Street address
University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Babol University of Medical Sciences
Full name of responsible person
Soleiman Mahjoub
Position
Ph.D. in Clinical Biochemistry
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Postal code
Phone
+98 11 3219 0569
Fax
Email
smahjoub20@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Soleiman Mahjoub
Position
Ph.D. in Clinical Biochemistry
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Postal code
Phone
+98 11 3219 0569
Fax
Email
smahjoub20@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Soleiman Mahjoub
Position
Ph.D. in Clinical Biochemistry
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0569
Fax
Email
smahjoub20@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)