Clinical trial NCT04116203: Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
Official title: Dietary Fish Oil Intervention in Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Polycystic Ovary Syndrome
Lipid Metabolism Disorders
Keywords: Polycystic Ovary Syndrome
metabolic and cardiovascular diseases
diabetes
obesity
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Women and Children's Health Research Institute, Canada
name: Canadian Institutes of Health Research (CIHR)
name: Alberta Diabetes Institute
name: Heart and Stroke Foundation of Canada
First posted: 2019-10-04
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Outcomes at 6 and 12 weeks will be compared to baseline values to determine the efficacy of interventions. Participants will act as their own control in each intervention
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state
timeFrame: At baseline and postintervention at 12 weeks
Secondary outcomes:
measure: Plasma insulin and glucose
timeFrame: At baseline and postintervention at 12 weeks
measure: Plasma hormones, testosterone, SHBG, Estrogen
timeFrame: At baseline and postintervention at 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: 9-111 Endocrinology Department, UofA Hospital
state: Alberta
city: Edmonton
country: Canada
facility: 2-004 Li Ka Shing Centre, UofA
state: Alberta
Study officials:
affiliation: Associate Professor
name: Donna F Vine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.