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Effects of Elaeagnus angustifolia L. on the lipid profiles in menopause women

Protocol summary

Summary
Goal key: Study of the effects of Elaeagnus angustifolia.L. on the lipid profile in menopausal women In Ancient Iran,Elaeagnus angustifolia.L is a symbol of reproduction. In addition, it is a symbol of women's fertility. this plant has glucose and fructose are the most important carbohydrates and two phytosterols have been detected in Eangustifolia L. phyto estrogen is similar to estrogen. phytoestrogen is an estrogenic agonist and can induce similar effects in postmenopausal women.Although the efficacy of this plant in various cases such as fever, jaundice, ulcers and lung problems such as asthma and dyspnea, nausea, vomiting, amoeba diarrhea, vomiting, rheumatoid arthritis and etc been investigated, Its effect has not yet been studied in postmenopausal women. If the Eangustifolia L can have an effect on the estrogen secretion effect on lipid profiles in postmenopausal women, it can be a good food option for women after menopause. method: referring to the Kamali clinic and oral invitation to collaborate, they will start randomly with the questionnaire of volunteers for their collaboration in the research. There will be 30 volunteers in each intervention and placebo group.this clinical trial is double blind and parallel, after the initial tests, 60 women will be selected to participate in the project. inclusion criteria: The menopausal women age of 40-70 with a serum lipid level of 200-300 mg / ml and a risk factor for not using the drug to reduce this lipid level are invited to this study. exclusion criteria: patient who suffer from cardiovascular, renal, and metabolic diseases such as diabetes, or psychosocial drugs or cigarettes, hookahs, alcoholics, and opiates, are excluded from the study. Interventions: Intervention group: 30 ladies receiving 15 grams per day of fine fruit powder for 10 weeks. placebo group: 30 ladies receiving 15 grams per day of isomalt and corn starch for 10 weeks. Main outcome variables: Insulin, LDL, HDL, TG, blood pressure, HbA1C

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017073132795N3
Registration date: 2017-10-11, 1396/07/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-11, 1396/07/19
Registrant information
Name
Arezou Rezaei
Name of organization / entity
Damghan university
Country
Iran (Islamic Republic of)
Phone
+98 23 3522 0081
Email address
arezaei@du.ac.ir
Recruitment status
Recruitment complete
Funding source
Damghan UniversityAlborz University
Expected recruitment start date
2017-08-05, 1396/05/14
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Elaeagnus angustifolia L. on the lipid profiles in menopause women
Public title
Effects of Elaeagnus angustifolia L. on lipid profile in menopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Postmenopausal women aged 70-40 with a serum lipid level of 200-300 mg / ml and no risk factor for using the drug to lower this lipid level are invited to this study. Major exclusion criteria: The women who suffering from cardiovascular diseases; renal and metabolic disorders such as diabetes; those using psychiatric drugs; smoking tobacco or consuming alcohol or narcotic agents are excluded from the study.
Age
From 40 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, administrative city, north Taleghani avenue, Karaj, Alborz
City
Karaj
Postal code
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
Abzums.Rec.1396.87

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.9
ICD-10 code description
Menopausal and perimenopausal disorder, unspecified

Primary outcomes

1

Description
LDL
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

2

Description
HDL
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

3

Description
Triglyceride
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

4

Description
Insulin
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

5

Description
HbA1c
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

6

Description
Blood pressure
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

7

Description
Total Protein
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

Secondary outcomes

1

Description
Constipation, Abdominal Pain
Timepoint
End of the course after 10 weeks
Method of measurement
Standards of medical diagnostic laboratories

Intervention groups

1

Description
Intervention group: Elaeagnus angustifolia L powder, 15 g / day longer 10 weeks.
Category
Treatment - Drugs

2

Description
Control group(placebo):7.5 g isomalt and 7.5 g corn starch longer 10 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Clinic
Full name of responsible person
Dr. Bita Badehnoosh
Street address
Kamali clinic, after the first underpass, Shohada square toward foursquare Tleghani, Kraj
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Damghan university
Full name of responsible person
Dr Seyed Ali Pour Mousavi,Vice chancellor for research
Street address
Vice chancellor for research,Damghan university, University square, Damghan city.
City
Damghan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Damghan university
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Alborz university of medical sciences
Full name of responsible person
Dr Mohammad Noori Sepehr, Vice chancellor for research
Street address
Vice chancellor for research, Alborz university of medical sciences, administrative city, Taleghani square, Karaj
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz university of medical sciences
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
Iran Zamin laboratory
Full name of responsible person
Alireza Mohammad Yari
Street address
Iran Zamin laboratory,underground of DR Asgari drugstore, side of Eram tower,Taleghani intersection, Karaj
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Zamin laboratory
Proportion provided by this source
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
Damghan University
Full name of responsible person
Mahzad SHaabani
Position
Masters student
Other areas of specialty/work
Street address
College of Biology, University of Damghan, Damghan
City
Damghan
Postal code
Phone
+98 11 4308 3625
Fax
Email
mahzadsh70@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Damghan university/Alborz University of Medical Sciences
Full name of responsible person
Dr Arezoo Rezaei/Dr BitaBadehnoosh
Position
Biochemistry phD- bstetrics and Gynecology
Other areas of specialty/work
Street address
College of Biology, University of Damghan, Damghan Square ,Damghan / Alborz University of Medical Sciences, North Taleghani avenue, Taleghni Square , Karaj, Alborz
City
Damghan/Karaj
Postal code
Phone
+98 912 332 5792
Fax
Email
arezaei@du.ac.ir; badehnoosh@abzums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Damghan University
Full name of responsible person
Arezou Rezaei
Position
Biochemistry phd
Other areas of specialty/work
Street address
Damghan University, University Square, Damghan city
City
Damghan
Postal code
Phone
+98 23 3522 0081
Fax
+98 23 3522 0223
Email
arezaei@du.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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