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Completed

NCT Number: NCT01189669

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Day Centre, The Adelaide and Meath Hospital, Dublin, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LC n-3 PUFA (fish oil) Supplement

Dietary Supplement

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

Other names: LC n-3 PUFA (fish oil), Placebo (PL), Wash-out (WO)

Placebo (olive oil) supplement

Dietary Supplement

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

Primary outcomes

  1. Fasting lipid metabolism

    Time frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks

Secondary outcomes

  1. Plasma hormonal profile

    Time frame: Following supplementation with LCn-3PUFA or placebo for 6 weeks

  2. Postprandial lipid metabolism

    Time frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks

Sponsors and collaborators

Lead sponsor

The Adelaide and Meath Hospital

Other

Collaborators

  • University College Dublin

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 27, 2010
Registry last updated
Sep 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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