Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
Study NCT ID:
NCT04116203
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2018-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCOS
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: