Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

Official title:

Dietary Fish Oil Intervention in Polycystic Ovary Syndrome

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04116203
• Other study ID #: PRO00059201
• Status: Suspended
• Phase: Phase 1
• Start date: June 30, 2016
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.

Description:

Specific Objectives; 1. To determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations. 2. To determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apoB-lipoprotein kinetics. We will quantitate the in vivo production and kinetics of plasma TG, apoB48 and apoB100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods. 3. To explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apoB-lipoprotein metabolism.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 180
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Female
• Age at time of enrollment > 18 to <30 years
• Diagnosis of PCOS: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders.
• Overweight-obese (BMI >25 kg/m2) high-risk metabolically-resistant young women.
• Elevated fasting plasma TG (>150 mg/dL) and apoB48-remnant cholesterol lipoproteins (>20 ug/ml).
• Impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin >15 (uM/ml); and
• May be diagnosed with T2D (blood glucose >126 mg/dL).

Exclusion Criteria:

• Pregnancy
• Lactating women
• Recent illness that the investigator determines to pose a potential risk for the participant
• Concomitant medications that influence metabolism (e.g. statins)
• Excessive alcohol consumption, as determined by the investigator.

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Metabolic Diseases
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
Manufacturer's standard 500 mg. Submission Control No.:128147

Combination Product:
• Fish Oil and Metformin
Combo of 2 other arms

Dietary Supplement:
• Fish Oil
NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral

Locations

Country	Name	City	State
Canada	2-004 Li Ka Shing Centre, UofA	Edmonton	Alberta
Canada	9-111 Endocrinology Department, UofA Hospital	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	Alberta Diabetes Institute, Canadian Institutes of Health Research (CIHR), Women and Children's Health Research Institute, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Vine DF, Wang Y, Jetha MM, Ball GD, Proctor SD. Impaired ApoB-Lipoprotein and Triglyceride Metabolism in Obese Adolescents With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Mar 1;102(3):970-982. doi: 10.1210/jc.2016-2854. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state	reported as mean +/- SEM	At baseline and postintervention at 12 weeks
Secondary	Plasma insulin and glucose	reported as mean +/- SEM	At baseline and postintervention at 12 weeks
Secondary	Plasma hormones, testosterone, SHBG, Estrogen	reported as mean +/- SEM	At baseline and postintervention at 12 weeks