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The effect of psyllium oral supplementation on insulin resistance and lipid profile in non diabetic patients with polycystic ovary syndrome

The effect of psyllium oral supplementation on insulin resistance and lipid profile in non diabetic patients with polycystic ovary syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016091929508N4
Enrollment
54
Registered
2016-10-18
Start date
2016-09-24
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: 5 grams of Psyllium twice daily for 2 month. Intervention 2: control group: 5 grams of Microcrystalline cellulose as a placebo, twice daily for 2 month.
Placebo
Intervention group: 5 grams of Psyllium twice daily for 2 month
control group: 5 grams of Microcrystalline cellulose as a placebo, twice daily for 2 month

Sponsors

Vice chancellor for research, Urmia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose (FBS). Timepoint: before intervention, 2 month after intervention. Method of measurement: mg/dl.;Fasting serum insulin. Timepoint: before intervention, 2 month after intervention. Method of measurement: µU/mL.;Triglyceride. Timepoint: before intervention, 2 month after intervention. Method of measurement: mg/dl.;Total Cholesterol. Timepoint: before intervention, 2 month after intervention. Method of measurement: mg/dl.;LDL-C. Timepoint: before intervention, 2 month after intervention. Method of measurement: mg/dl.;HDL-C. Timepoint: before intervention, 2 month after intervention. Method of measurement: mg/dl.;Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: before intervention, 2 month after intervention. Method of measurement: FBS*insulin/22.5.

Secondary

MeasureTime frame
Fat mass. Timepoint: before intervention, 2 month after intervention. Method of measurement: gr.;Body Mass Index (BMI). Timepoint: before intervention, 2 month after intervention. Method of measurement: kg/m2.;Fat Free Mass. Timepoint: before intervention, 2 month after intervention. Method of measurement: gr.;Waist to hip ratio (WHR). Timepoint: before intervention, 2 month after intervention. Method of measurement: waist/hip.;Number and regularity of menstrual cycle. Timepoint: before intervention, 2 month after intervention. Method of measurement: Ask a Question.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Rasoul Zarrin

Urmia University of Medical Sciences

wwzarrin@yahoo.com; Rasoul.Zarrin@uqconnect.edu.au+98 44 3346 9935

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026