Objectives: The aim of current study to determine the effect of oral psyllium supplementation on insulin resistance and lipid profile in non-diabetic patients with polycystic ovary syndrome.
Design: A randomized clinical trial, double-blind, placebo-controlled will be done on 54 females with polycystic ovary syndrome, non-diabetic.
Setting and conduct: Patients will be divided randomly into 2 groups, intervention group (5 grams of psyllium) and placebo group (microcrystalline cellulose as a placebo) twice daily for 8 weeks.
Participants: Inclusion criteria are including: patients who have FBS (fasting blood glucose) less than 126 mg /dl and age group 18 -45 years. Exclusion criteria: Subjects with diseases such as diabetes; congenital adrenal hyperplasia; Cushing's syndrome; thyroid disorders or corticosteroid consumers. Levels of fasting blood glucose, fasting insulin and lipid profile before and after intervention will be compared between two groups. Also, Diet and Anthropometric measurements of participants will be assessed in before and after the intervention duration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091929508N4
Registration date:2016-10-18, 1395/07/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-18, 1395/07/27
Registrant information
Name
Rasoul Zarrin
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
rasoul.zarrin@uqconnect.edu.au
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2016-09-24, 1395/07/03
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psyllium oral supplementation on insulin resistance and lipid profile in non diabetic patients with polycystic ovary syndrome
Public title
The effect of psyllium oral supplementation on insulin resistance and lipid profile in non diabetic patients with polycystic ovary syndrome
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Age range 18-45 years; PCOs diagnosis based on the Rotterdam; Persons with fasting glucose concentrations in the range of less than 126 mg /dl; Exclusion criteria: Smoker or addict; Individuals receiving glucose-lowering drugs other than Metformin; Corticosteroid consumer; Consumer drugs such as Lithium, Carbamazepine and Digoxin; Warfarin consumer; Individuals with a history of Myocardial Infarction, Kidney, Liver and Lung diseases; Individuals with Thyroid Dysfunction; Individuals with major surgery in the last 6 months; Individuals with a history of allergy to Psyllium and Aspartame; Patients with Phenylketonuria; Patients with type 1 diabetes, Gastrectomy and Parkinson's disease; Individuals with a history of Gastrointestinal Disease, particularly persistent constipation and narrowing and blockage of the intestinal tract; Individuals treated with drugs that affect blood lipid profile; Individuals with a history of diseases such as Congenital Adrenal Hyperplasia, Cushing's syndrome, Hyperprolactinemia, the androgen-secreting tumors and Thyroid disease; Patients treated with antidepressant medications and recent treatment for eating disorder; Individuals treated with other fiber supplements.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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, Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Jahad street, Resalt Ave, Urmia, Iran
City
Urmia
Postal code
Approval date
2016-08-31, 1395/06/10
Ethics committee reference number
Ir.umsu.rec.1395.223
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
fasting blood glucose (FBS)
Timepoint
before intervention, 2 month after intervention
Method of measurement
mg/dl
2
Description
fasting serum insulin
Timepoint
before intervention, 2 month after intervention
Method of measurement
μU/mL
3
Description
Triglyceride
Timepoint
before intervention, 2 month after intervention
Method of measurement
mg/dl
4
Description
Total Cholesterol
Timepoint
before intervention, 2 month after intervention
Method of measurement
mg/dl
5
Description
LDL-C
Timepoint
before intervention, 2 month after intervention
Method of measurement
mg/dl
6
Description
HDL-C
Timepoint
before intervention, 2 month after intervention
Method of measurement
mg/dl
7
Description
homeostasis model assessment of insulin resistance (HOMA-IR)
Timepoint
before intervention, 2 month after intervention
Method of measurement
FBS*insulin/22.5
Secondary outcomes
1
Description
Fat mass
Timepoint
before intervention, 2 month after intervention
Method of measurement
gr
2
Description
Body Mass Index (BMI)
Timepoint
before intervention, 2 month after intervention
Method of measurement
kg/m2
3
Description
Fat Free Mass
Timepoint
before intervention, 2 month after intervention
Method of measurement
gr
4
Description
Waist to hip ratio (WHR)
Timepoint
before intervention, 2 month after intervention
Method of measurement
waist/hip
5
Description
Number and regularity of menstrual cycle
Timepoint
before intervention, 2 month after intervention
Method of measurement
Ask a Question
Intervention groups
1
Description
Intervention group: 5 grams of Psyllium twice daily for 2 month
Category
N/A
2
Description
control group: 5 grams of Microcrystalline cellulose as a placebo, twice daily for 2 month