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The effect of Cornus mas extract on blood glucose, lipids profiles and leptin in postmenopausal women: An double blind clinical trial

Protocol summary

Summary
Objectives: The aim of this double-blind Randomized Controlled Trial study is evaluation of the effect of Cornus mas extract on lipids and blood glucose profiles and leptin in postmenopausal women. Study population and sample size: 84 menopause women (45 to 60 years old) referred to Rassol Akram hospital in Tehran. Inclusion and exclusion criteria: women with menopause who have experienced at least one year after amenorrhea history. They shouldn't: have history of malignancies, have active hepatic or renal disease, take HRT or take progesterone, intake of medicines which have effect on blood sugar or blood lipids and consumption of cornus mas. Samples will be divided into two groups to take 3 capsules containing 300mg Cornus mas extract or placebo starch powder for 8 weeks. Randomization will be done using a software through a computer. At the start of intervention, questionnaires of 24-hour Dietary Recall, physical activity (IPAQ), and general information will be filled out; height and weight will be measured, too. Afterwards 10cc venous blood sample will be taken to measure FBS, Serum Insulin, lipid profiles including Total cholesterol, HDL-chol,LDL-chol, TG and also ApoA1, Apob100, Leptin level, and Fibrinogen level. At the end of the intervention blood sample will be taken again and aforementioned tests will be repeated again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201610259472N10
Registration date: 2016-12-20, 1395/09/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-20, 1395/09/30
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-10-29, 1395/08/08
Expected recruitment end date
2017-10-30, 1396/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of Cornus mas extract on blood glucose, lipids profiles and leptin in postmenopausal women: An double blind clinical trial
Public title
The effect of Cornus mas extract on Blood Glucose and lipids in postmenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: at least 12 month of amenorrhea; No history of allergies to cornus mas fruit and products; No HRT or other menopausal treatments during last 6 months; no intake of progesterone; No intake of medicines which have effect on blood sugar, blood pressure, or blood lipids; No abnormal vaginal bleeding; No kidney or liver active illness or Inflammation (No history of Malignity); No consumption of soy or vegan diet; No history of thromboembolism; No consumption of Nutritional supplement in the past 3 months (Omega 3 and antioxidant); No drinking alcohol or smoking habit ; ability to recognize and understand the purpose of study; ability to read and write Exclusion criteria: history of allergies to cornus mas fruit and products; HRT or other menopausal treatments during last 6 months; Hysterectomy; intake of progesterone; intake of medicines which have effect on blood sugar, blood pressure, or blood lipids; abnormal vaginal bleeding; kidney or liver active illness or Inflammation ( history of Malignity); consumption of soy or vegan diet; history of thromboembolism; consumption of Nutritional supplement in the past 3 months (Omega 3 and antioxidant); drinking or smoking habit
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be done using a software through a computer.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences , The intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemman highway
City
Tehran
Postal code
Approval date
2016-09-24, 1395/07/03
Ethics committee reference number
IR.IUMS.REC 1395.9313680004

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
before intervention, after intervention
Method of measurement
biochemical tests

2

Description
Serum fasting insulin
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical tests

3

Description
Serum fasting cholestrol
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical tests

4

Description
Serum fasting triglycerid
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical tests

5

Description
LDL cholestrol
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical tests

6

Description
HDL cholestrol
Timepoint
Before intervention, after 2 month intervention
Method of measurement
Biochemical tests

7

Description
ApoA1
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical tests

8

Description
ApoB100
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical tests

9

Description
Leptin
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical tests

Secondary outcomes

1

Description
Fibrinogen
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical tests

Intervention groups

1

Description
The intervention group will receive 3 capsules containing 300 mg of powdered Cornus mas, daily, for 8 weeks. These capsules have been produced by Barij Essence Pharmaceutical Company
Category
Treatment - Drugs

2

Description
Control group will receive 3 capsules containing 300 mg starch powder as placebo, daily, for 8 weeks, produced by Barij Essence Pharmaceutical Company
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e-akram hospital
Full name of responsible person
Dr. Naheed Aryaeian
Street address
Niayesh Av, Sattar khan st, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Ali Javad Moosavi
Street address
Iran University of Medical Sciences,The intersection of Sheikh Fazlallah and Shahid Chamran,Shahid Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Naheed Aryaeian
Position
Phd in Nutrition
Other areas of specialty/work
Street address
Nutrition Department, School of public health, Iran University of Medical Sciences, the intersection of Sheikh Fazlallah and Chamran, Shahid Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
aryaeian.n@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Naheed aryaeian
Position
Nutrition PhD
Other areas of specialty/work
Street address
Nutrition Department, School of public health, Iran University of Medical Sciences, The intersection of Sheikh Fazlallah and Chamran, Shahid Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
n-aryaeian@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Afsane Gholamrezayi
Position
Master degree student of nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, School of health ,Iran University of Medical Sciences,The intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat highway
City
Tehran
Postal code
Phone
Fax
Email
afsane.rezayi@yahoo.com
Web page address

Sharing plan

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