Objective: To determine the effect of cinnamon capsules on some lipid and blood sugar in overweight or obese women with polycystic ovary syndrome in women referred to clinics affiliated to Shiraz University of Medical Sciences in 2016
this study is Controlled, single-blind randomized clinical trial
Study population: All women of childbearing age (18-40 years) women with polycystic ovary who referred to clinic of Shiraz University of Medical Sciences
The main inclusion criteria:want to participate in study-Study, diagnosis of polycystic ovary syndrome by a gynecologist- having a body mass index of 25 or more-the age range between18-40
do not have any previous allergy to cinnamon
the main exclusion criteria
do not want to continue the study-The incidence of any adverse allergic to cinnamon consumption-pregnancy
sample size:62 people
intervention:They were randomly divided into control and experimental groups and use three grams of cinnamon powder or cellulose as placebo capsules daily for two months.Before and after the intervention blood sample will taken to assess lipid and blood sugar profiles
Consequences:Is expected to follow the consumption of cinnamon lipid and blood sugar profile levels reduced or adjusted index
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122025618N1
Registration date:2016-01-25, 1394/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Mehrnoosh Hatamzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3831 1946
Email address
stud2301111741@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-03, 1394/10/13
Expected recruitment end date
2016-07-03, 1395/04/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of cinnamon powder capsule on some of lipid and blood sugar profile in overweight or obese women with polycystic ovary syndrome
Public title
the effect of cinnamon on lipid and blood sugar in polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:people who want to participate in study and full fill the informed consent form;Before choosing the sample, polycystic ovarian syndrome diagnosed by the gynecologist based on Rotterdam criteria;people have body mass index 25 or more;people age range is between18-40;have not Previous history of allergy to cinnamon consumption;do not have hypertension;do not have diabetes mellitus;do not have cardio vascular disease;do not have hepatic disease;do not have renal disease;do not have Cerebrovascular disease;do not have Seizure disorders;do not have Increased levels of the prolactin or other endocrine disorders;do not have Hypothyroidism or hyperthyroidism;do not have adrenal disorders;do not have cancer;do not have infertility;do not have history of alcohol use or smoking;do not use hormone therapy during three months prior to study;do not use hormonal contraception during three months prior to study;do not use insulin sensitizing drug during three months prior to study;do not be during pregnancy or breast feeding period;
exclusion criteria
do not want to continue the study;In case of any allergic symptoms after taking cinnamon;cinnamon consumption cut and will be excluded;In the event of pregnancy;cinnamon consumption cut and will be excluded;In case of loss of any inclusion criteria drug use will be cut and people excluded from the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences,Zand Street, Shiraz
Kilograms per height in square meters by the formula
2
Description
weight
Timepoint
before study and after study
Method of measurement
kilogram by using scale
3
Description
height
Timepoint
before intervention and after intervention
Method of measurement
centimetre by using metre
4
Description
fasting glucose
Timepoint
before intervention and after intervention
Method of measurement
Milligrams per deciliter by use blood samples and laboratory testing
5
Description
fasting insulin
Timepoint
before intervention and after intervention
Method of measurement
Micro units per milliliters of blood samples and laboratory testing
6
Description
Insulin resistance
Timepoint
before intervention and after intervention
Method of measurement
by using formula
7
Description
Oral glucose tolerance test
Timepoint
before intervention and after intervention
Method of measurement
Milligrams per deciliter by using blood sample and laboratory testing
8
Description
Cholesterol
Timepoint
before and after intervention
Method of measurement
Milligrams per deciliter by using blood samples and laboratory testing
9
Description
low density lipoprotein
Timepoint
before and after intervention
Method of measurement
Milligrams per deciliter by using blood samples and laboratory testing
10
Description
high density lipoprotein
Timepoint
before and after intervention
Method of measurement
Milligrams per deciliter by using blood samples and laboratory testing
11
Description
triglyceride
Timepoint
before and after intervention
Method of measurement
Milligrams per deciliter by using blood samples and laboratory testing
Secondary outcomes
1
Description
abdominal pain
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
2
Description
itching
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
3
Description
headache
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
4
Description
hives
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
5
Description
asthma
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
6
Description
Respiratory allergies
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
7
Description
diarrhea
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
8
Description
nausea
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
9
Description
heartburn
Timepoint
before and during and after intervention
Method of measurement
Periodic follow-up by telephone call
Intervention groups
1
Description
the intervention group use cinnamon powder capsules three times a day and each time two 500- milligram capsules(a total of 3 grams per day) orally for two months
Category
Treatment - Drugs
2
Description
control group use cellulose capsule three times a day and each time two 500-miligram capsules (a total of three grams per day) orally for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic of Faghihi Hospital
Full name of responsible person
Doctor Fatemehsadat Najib(Gynecologist-Assistant professor)
Street address
Faghihi Hospital،Zand street،Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Motahari Clinic(Gynecology Clinic)
Full name of responsible person
Doctor Fatemehsadat Najib(Gynecologist-Assistant professor)
Street address
Motahari Clinic،Namazi Square،Shiraz
City
Shiraz
3
Recruitment center
Name of recruitment center
Clinic of Zeinab Hospital
Full name of responsible person
Doctor Fatemehsadat Najib(Gynecologist-Assistant professor)
Street address
Zeinab Hospital،Defamoghaddas Square،Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shiraz universirty of medical sciences
Full name of responsible person
Vice President of Research and Technology
Street address
shiraz-zand street-Central Building of shiraz University of Medical Sciences
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shiraz universirty 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
Fatemeh School of Nursing and Midwifery، Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Moshfeghy
Position
Master of Midwifery
Other areas of specialty/work
Street address
Fatemeh School of Nursing and Midwifery،Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3647 4252
Fax
Email
zmoshfeghy1385@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh School of Nursing and Midwifery،Shiraz Universty of Medical Sciences
Full name of responsible person
Zeinab Moshfeghy
Position
Master of Midwifery
Other areas of specialty/work
Street address
Fatemeh School of Nursing and Midwifery،Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3647 4252
Fax
Email
zmoshfeghy1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh School of Nursing and Midwifery،Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoosh Hatamzadeh
Position
Midwifery Students
Other areas of specialty/work
Street address
Fatemeh School of Nursing and Midwifery،Namazi Square