Objection of study: To Determine the effect of cinnamon on Antioxidant status in patients with polycystic ovarian syndrome.
Design
Randomized, double-blind, placebo-controlled.
Population studied: Individuals with polycystic ovarian syndrome were randomly divided into 2 groups for 8 weeks, group1 receiving cinnamon (3 capsule 500 mg),group 2 placebo group (3 capsule 500 mg placebo), Sample size: 84 people (2 groups of 42). Study Intervention: cinnamon Supplement
Settings and conduct
The aim of this study was to evaluate the effect of cinnamon supplementation on antioxidant status in patients with PCOS. For each person, the general characteristics questionnaire, anthropometric evaluations, Food registration and the International Assessment of Physical Activity (IPAQ) will be completed. To measure all biochemical parameters, 10 cc of venous blood is collected fast (at the beginning and end of the study).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female:20-38 years old, 25≤BMI>40; At least two standard measurement of amenorrhea or oligomenorrhea; Clinical or laboratory hyperandrogenism and Polycystic Ovary on ultrasonography . Exclusion criteria: Thyroid disorders; Hyperprolactinemia, Cushing's syndrome; Liver and kidney diseases; Cardiovascular disease; High blood pressure and diabetes; Pregnant and lactation women; Consumers of anti-obesity and blood lipid-lowering drugs; Anticoagulants and glucocorticoids drugs; Loss weight diet; Smokers; Very active and athletes ; Allergic to cinnamon; Seizure and epilepsy disorders ; Cerebrovascular disorders; Individuals undergoing infertility treatments and beta-blockers.
Intervention groups
group 1 receiving cinnamon (3 capsule 500 mg) group 2 placebo group (3 capsule 500 mg placebo)
Main outcome variables
Effect of cinnamon supplementation on antioxidant status in patients with polycystic ovary syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100408003664N22
Registration date:2018-10-07, 1397/07/15
Registration timing:registered_while_recruiting
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cinnamon supplementation on antioxidant status in patients with polycystic ovary syndrome
Public title
Effect of cinnamon supplementation on antioxidant status in patients with polycystic ovary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Female:20-38 years old, 25≤BMI>40; At least two standard measurement of amenorrhea or oligomenorrhea; Clinical or laboratory hyperandrogenism and polycystic ovary on ultrasonography .
Exclusion criteria:
Exclusion criteria: Thyroid disorders; Hyperprolactinemia, Cushing's syndrome; Liver and kidney diseases; Cardiovascular disease; High blood pressure and diabetes; Pregnant and lactation women; Consumers of anti-obesity and blood lipid-lowering drugs; Anticoagulants and glucocorticoids drugs; Loss wieght diet; smokers; Very active and athletes; Allergic to cinnamon; Seizure and epilepsy disorders ; Cerebrovascular disorders; Individuals undergoing infertility treatments and beta-blockers.
Age
From 20 years old to 38 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
Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age and BMI variables.
Blinding (investigator's opinion)
Double blinded
Blinding description
A placebo and supplement will be packed in the same number in similar envelopes. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Science
Street address
Tabriz University of Medical Science, Nutrition Faculty, Attar Neyshabori, Goldasht street, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5138663134
Approval date
2018-09-10, 1397/06/19
Ethics committee reference number
IR.TBZMED.REC.1397.493
Health conditions studied
1
Description of health condition studied
Polycystic Ovarian Syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Malondialdehyde (MDA)
Timepoint
Begining and end of the intervention
Method of measurement
Serum kit
2
Description
total antioxidant capacity(TAC)
Timepoint
Begining and end of the intervention
Method of measurement
Serum kit
Secondary outcomes
1
Description
Physical activity
Timepoint
Beginning and end of intervention
Method of measurement
questioner
2
Description
Diet
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
3-day food record
Intervention groups
1
Description
Intervention group: 3 capsules of 500 mg cinnamon daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Plasebo: 3 capsule 500 mg daily, 8 weeks