The aim of this study is to determine the effects of Spirulina supplementation on metabolic factors in patients with Polycystic Ovary Syndrome.
Design
Study design: parallel double-blind (both patients and researchers) clinical trial. Sample size 86, phase 3. Randomization will be done using the lottery method.
Settings and conduct
Patients with Polycystic Ovary Syndrome referred to Farhikhtegan hospital affiliated to Islamic Azad University.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with Polycystic Ovary Syndrome based on the Rotterdam criteria in the age range of 18 to 45 years. Not following a special diet. Not addicted to alcohol or drug abuse. The patient should not be pregnant or breastfeeding.
Criteria for not entering the study: history of oophorectomy, use of antidepressants, use of weight loss or appetite suppressants.
Intervention groups
Study intervention: Patients will be assigned to two groups of intervention (n=43) or control (n=43) to receive spirulina supplement or placebo. Spirulina and placebo supplement capsules are similar in shape and size. Fasting blood samples will be taken from the patients at the beginning of the study and 12 weeks after the intervention. Intervention time: 3 months.
Main outcome variables
Outcomes: Insulin metabolism markers (primary outcomes) and Blood Glucose and HemoglobinA1C and lipid profiles (secondary outcomes) will be measured at the beginning and end of the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220909055921N1
Registration date:2023-10-23, 1402/08/01
Registration timing:prospective
Last update:2023-10-23, 1402/08/01
Update count:0
Registration date
2023-10-23, 1402/08/01
Registrant information
Name
Rezvan Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 5601
Email address
rezvan.mohammadi@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-28, 1402/08/06
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Effects of Spirulina Supplementation on Metabolic Factors in Polycystic Ovary Syndrome Patients
Public title
Effect of Supplementation in Polycystic Ovary Syndrome Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome according to the Rotterdam criteria
Age range from 18 to 45 years
Not following a special diet
Not addicted to alcohol or drug abuse
The patient should not be pregnant or breastfeeding
Exclusion criteria:
History of oophorectomy
Use of antidepressants
Use of weight loss or appetite suppressants
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done in a simple random way using a lottery. In this way, a number or code is assigned to each patient and it is placed in a container and stirred. Out of 86 people, the first 43 people are in group A and the rest take in group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Spirulina supplement and Placebo were divided into two groups A and B by the manufacturer. Participants and researchers or outcome assessors know which group each patient received but are unaware of study group allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnics committee of Farhikhtegan Hospital
Street address
Daneshgah Ave.,Hesarak
City
Tehran
Province
Tehran
Postal code
1477899679
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.IAU.FARHIKHTEGANH.REC.1402.002
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
Serum High-Density Lipoprotein
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
Enzymatic method using Autoanalyzer
2
Description
Total Serum Cholesterol
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
Enzymatic method using Autoanalyzer
3
Description
Fasting Blood Sugar
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
Elisa Kit
4
Description
Total Serum Triglyceride
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
Enzymatic method using Autoanalyzer
5
Description
Serum Low-density Lipoprotein
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
Enzymatic method using Autoanalyzer
6
Description
Serum Insulin
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
Microunits per Milliliter,Enzyme immunoassay test(ELISA)
7
Description
HemoglobinA1C
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
High Performance Liquid Chromatography with Ion Exchange
Secondary outcomes
1
Description
Insulin Resistance Index
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
Formula
2
Description
Blood Pressure
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
mmHg, Barometer
3
Description
Weight
Timepoint
The first day of the study and the last day of the 12th week
Method of measurement
Kilogram-Scale
4
Description
Body Mass Index
Timepoint
The first day of the study and the last day of the 12th week