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

Long Chain (LC) n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS): A Cross-over, Placebo Controlled Dietary Intervention Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01189669
Enrollment
25
Registered
2010-08-27
Start date
2007-09-30
Completion date
2008-07-31
Last updated
2010-09-13

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

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

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.

Interventions

4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks

DIETARY_SUPPLEMENTPlacebo (olive oil) supplement

4 x 1g olive oil capsules were given daily for 6 weeks

Sponsors

University College Dublin
CollaboratorOTHER
The Adelaide and Meath Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Fasting lipid metabolismFollowing supplementation with LCn-3 PUFA or placebo for 6 weeks

Secondary

MeasureTime frame
Postprandial lipid metabolismFollowing supplementation with LCn-3 PUFA or placebo for 6 weeks
Plasma hormonal profileFollowing supplementation with LCn-3PUFA or placebo for 6 weeks

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026