n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: LC n-3 PUFA (fish oil) Supplement; Dietary Supplement: Placebo (olive oil) supplement

• Registration Number: NCT01189669
• Lead Sponsor: The Adelaide and Meath Hospital

Brief Summary

This is a dietary intervention study designed to assess the impact of long chain (LC) n-3 polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS). Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.

Detailed Description

Polycystic ovary syndrome (PCOS) is a chronic condition affecting young women of reproductive age. Long-term, safe and efficacious treatments are needed for women with this condition, and dietary therapy may have an important role in its treatment. LC n-3 PUFA have been shown to be potent biological regulators, involved in the amelioration of many of the adverse metabolic risk factors which are often present in women with PCOS. The aim of this study was to explore the impact of LC n-3 PUFA on fasting and post-prandial lipid metabolism, as well as on the hormonal profile of women with PCOS.

Study Timeline

• Study Start: 2007-09
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
• Were between the ages of 18 and 40

Exclusion Criteria

• Were under 18 years or greater than 40 years old,
• Were non-Caucasian
• Were pregnant, lactating or trying to conceive
• Had a body mass index (BMI) <18kg/m2 or >50kg/m2
• Had a recent illness or any chronic illness likely to influence results
• Were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents
• Were taking nutritional supplements
• Consumed greater than 2 portions of oily fish per week

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LC n-3 PUFA	LC n-3 PUFA (fish oil) Supplement	Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks.
Placebo (olive oil) supplement	Placebo (olive oil) supplement	4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Fasting lipid metabolism	Following supplementation with LCn-3 PUFA or placebo for 6 weeks

Secondary Outcome Measures

Name	Time	Method
Plasma hormonal profile	Following supplementation with LCn-3PUFA or placebo for 6 weeks
Postprandial lipid metabolism	Following supplementation with LCn-3 PUFA or placebo for 6 weeks

Trial Locations

Locations (2)

Diabetes Day Centre, The Adelaide and Meath Hospital; 🇮🇪 Dublin, Ireland

Nutrigenomics Research Group, UCD; 🇮🇪 Dublin, Ireland