Protocol summary

Summary
In this study, the effects of green tea consumption on markers of oxidative stress in Alzheimer's disease, was investigated. In this study, we enrolled thirty patients with severe probable AD. The diagnostic criteria was 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 was lower than 24 (MMSE) and age was higher than 67. Inflammatory and infectious diseases, vitamins and folic acid supplementation were the exclusion criteria. Patients consumed four green tea pills per day for two months (2g per day in 2 divided doses. Plasma total antioxidant capacity levels, 8-hydroxy-2'-deoxyguanosine levels, malondialdehyde levels, carbonyl content levels were measured before and after dietary intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402233684N5
Registration date: 2015-08-15, 1394/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-15, 1394/05/24
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
Babol University of Medical Sciences
Expected recruitment start date
2014-04-19, 1393/01/30
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of green tea consumption on markers of oxidative stress in Alzheimer's patients
Public title
The effect of green tea in the treatment of Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Alzheimer's disease Inclusion Exclusion: Taking vitamin and antioxidant supplements; drugs interfering; inflammatory diseases; acute and chronic infectious disease; thalassemia; diabetes; hepatitis
Age
From 67 years old to 100 years old
Gender
Both
Phase
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)
Not 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
Gange afrose st, Babol
City
Babol
Postal code
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
3609

Health conditions studied

1

Description of health condition studied
Alzheimer
ICD-10 code
G30.8
ICD-10 code description
Other Alzheimer disease

Primary outcomes

1

Description
Malondialdehyde
Timepoint
Before intervention, 2 months after the end of intervention
Method of measurement
TBARS Method (spectrophotometry)

2

Description
Total antioxidant capacity
Timepoint
Before intervention, 2 months after the end of intervention
Method of measurement
FRAP Method

3

Description
8-OH-2-deoxy-Guanosine
Timepoint
Before intervention, 2 months after the end of intervention
Method of measurement
ELISA

4

Description
Carbonyl
Timepoint
Before intervention, 2 months after the end of intervention
Method of measurement
Levin Method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention :Green tea,2 mg orally tablets, 2 times a day for 2 months
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehravaran Shomal nursing home
Full name of responsible person
Dr. Mehdi Moghadasi
Street address
Keshavarz Blvd, Sari, Mazandaran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences Research ِDeputy
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical Sciences, Ganj afrooz st, Babol
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 Research ِDeputy
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
Hourolein Arab
Position
MSc in Clinical Biochemistry
Other areas of specialty/work
Street address
Department of Biochemistry, Babol University of Medical Sciences, Ganj afrooz st, Babol
City
Babol
Postal code
Phone
+98 11 3326 8605
Fax
Email
hourolein.arab@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Prof.Soleiman Mahjoub
Position
PhD in Clinical Biochemistry
Other areas of specialty/work
Street address
Department of Biochemistry, Babol University of Medical Sciences, Ganj afrooz st, Babol
City
Babol
Postal code
47176-47745
Phone
+98 11 1219 0569
Fax
Email
smahjoub20@yahoo.com s.mahjoub@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Prof.Soleiman Mahjoub
Position
PhD in Clinical Biochemistry
Other areas of specialty/work
Street address
Department of Biochemistry, Babol University of Medical Sciences, Ganj afrooz st, Babol
City
Babol
Postal code
Phone
00
Fax
Email
smahjoub20@yahoo.com s.mahjoub@mubabol.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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