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Clinical trial comparing the effect of Green Tea extract and placebo on serum lipid profiles in postmenopausal women

Protocol summary

Summary
This study investigated the effects of Green Tea extract on serum lipid profiles in postmenopausal women deals. The subjects are women 45 to 65 years old with at least one year of their natural menstrual passes and history of any Thyroid disease, Diabetes, Stroke, Coronary artery disease, Liver disease, Gallbladder removal or taking prescription drugs such as, Aspirin, female hormones, Lithium, Corticosteroids, Warfarin and supplements containing antioxidants do not report. Intended sample size for this study, 100 women volunteered that the people referred to clinic are selected. First, any eligible candidate (according to inclusion and exclusion criteria) to measure blood lipid profiles (Total Cholesterol, Triglycerides, Low-Density Lipoprotein and High-Density Lipoprotein) will be taken. Reported in at least one case of borderline values of individual profiles will be selected as the study sample. Sampling will be conducted until the sample is completed. Because the study is double-blind, packets are encoded capsules (each capsule containing placebo or 400 mg of green tea extract) are distributed randomly among the subjects. Domestic drug consumption is 2 capsules after breakfast and dinner daily. Tests will be repeated again one month after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014021816625N1
Registration date: 2014-05-23, 1393/03/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-23, 1393/03/02
Registrant information
Name
Samaneh Movahedi zadeh
Name of organization / entity
Ahvaz, Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8331
Email address
movahedi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz, Jundishapur University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-06-05, 1393/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effect of Green Tea extract and placebo on serum lipid profiles in postmenopausal women
Public title
Effects of Green Tea on blood lipids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Over at least one year of normal menstruation; Report one or more of the lipid parameters in the borderline range; Age range 45 to 65 years. Exclusion criteria: Thyroid disorders including Hypothyroidism and Hyperthyroidism, Diabetes, Hypertension, Kidney failure, Liver disease, Coronary artery disease and cancer; Removal of the Gallbladder; A history of Stroke or Heart attack; Consumption of herbal medicines to improve metabolic abnormalities and Hypertension in three months; Following the departure of abnormal uterus and ovaries menopause; Smoking, drugs or Alcohol; Caffeine sensitivity; Use of medications such as Aspirin, female hormones, Lithium, corticosteroids, Warfarin, and supplements containing antioxidants; Non- pharmacological interventions to improve metabolic disorders such as regular exercise, Yoga and acupressure; Regular consumption of Green Tea daily
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz, Jundishapur University of Medical Sciences
Street address
Golestan boulevard
City
Ahvaz
Postal code
6135715794
Approval date
2013-09-28, 1392/07/06
Ethics committee reference number
ajums.REC.1392,216

Health conditions studied

1

Description of health condition studied
hyperlipidaemia
ICD-10 code
E78.2
ICD-10 code description
Hypercholesterolaemia with endogenous hyperglyceridaemia

Primary outcomes

1

Description
Total Cholesterol
Timepoint
Before the intervention and one month after intervention
Method of measurement
Measurement of serum Total Cholesterol levels after 12 hours of fasting

2

Description
Triglycerides
Timepoint
Before the intervention and one month after intervention
Method of measurement
Measurement of serum Triglycerides levels after 12 hours of fasting

3

Description
Low Density Lipoprotein (LDL)
Timepoint
Before the intervention and one month after intervention
Method of measurement
Measurement of serum Low Density Lipoprotein (LDL) levels after 12 hours of fasting

4

Description
High Density Lipoprotein (HDL)
Timepoint
Before the intervention and one month after intervention
Method of measurement
Measurement of serum High Density Lipoprotein (HDL) levels after 12 hours of fasting

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before the intervention, 2 weeks and 4 weeks after intervention
Method of measurement
Medical manometer

2

Description
Fasting blood sugar
Timepoint
Before the intervention and one month after intervention
Method of measurement
Measurement of serum Sugar levels after 12 hours of fasting

3

Description
Weight
Timepoint
Before the intervention and one month after intervention
Method of measurement
Analog scale

Intervention groups

1

Description
Green tea extract 800 mg per day in two capsules after breakfast and dinner
Category
Treatment - Drugs

2

Description
In two placebo capsules per day after breakfast and dinner
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center Shahrivar 17
Full name of responsible person
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz, Jundishapur University of Medical Sciences
Full name of responsible person
Dr Nader Saki
Street address
Golestan boulevard
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz, Jundishapur 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
Ahvaz, Jundishapur University of Medical Sciences
Full name of responsible person
Samaneh Movahedi zadeh
Position
Midwifery master student
Other areas of specialty/work
Street address
Golestan boulevard
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1336 7543
Fax
Email
movahedi.s@ajums.ac.ir; samane_movahedi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz, Jundishapur University of Medical Sciences
Full name of responsible person
Samaneh Movahedi zadeh
Position
Midwifery master student
Other areas of specialty/work
Street address
Golestan boulevard
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1336 7543
Fax
Email
movahedi.s@ajums.ac.ir; samane_movahedi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz, Jundishapur University of Medical Sciences
Full name of responsible person
Samaneh Movahedi zadeh
Position
Midwifery master student
Other areas of specialty/work
Street address
Golestan boulevard
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1336 7543
Fax
Email
movahedi.s@ajums.ac.ir; samane_movahedi@yahoo.com
Web page address

Sharing plan

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