Objection of study: To Determine the effect of cinnamon on metabolic status and serum levels of adiponectin in patients with polycystic ovarian syndrome. Study design: Random, double blind, Control with Placebo. Study population: Patients with Polycystic Ovarian Syndrome will be divided randomly into 2 intervention :1 -Cinnamon (receive 3 capsules containing 500 mg); 2-Placebo (receive 3 capsules containing 500 mg) for 2 months. 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. Sample size: 84 patients (42 patients in 2 groups). Study interventions: Cinnamon. Interventional duration: 8weeks. Primary outcome: The effec of supplements on metabolic status and serum levels of adiponectin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508173664N14
Registration date:2015-09-22, 1394/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-22, 1394/06/31
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
Tabriz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cinnamon supplementation on metabolic status and serum adiponectin levels in patients with Polycystic Ovary Syndrome
Public title
Effect of cinnamon supplementation in patients with Polycystic Ovary Syndrome
Purpose
Prevention
Inclusion/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 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
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 Tabriz University of Medical Science
Street address
Tabriz University of Medical Science, Nutrition Faculty, Attar Neyshabori, Goldasht street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2015-08-16, 1394/05/25
Ethics committee reference number
TBZMED.REC.1394.438
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
Metabolic status
Timepoint
Begining and end of the intervention
Method of measurement
Serum kit
Secondary outcomes
1
Description
Serum level of adiponectin
Timepoint
Beginig anf end of the intervention
Method of measurement
Serum kit
Intervention groups
1
Description
Intervention1: 3capsuls of 500 mg cinnamon daily for 8 weeks.