Trial | NCT01189669  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fish oil ...

  • Study Participants

    25
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.
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 Started
Sep 30
2007
Primary Completion
Jul 31
2008
Study Completion
Jul 31
2008
Last Update
Sep 13
2010
Estimate

Dietary Supplement LC n-3 PUFA (fish oil) 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)

Dietary Supplement Placebo (olive oil) supplement

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

Placebo (olive oil) supplement Placebo Comparator

4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.

Wash out period No Intervention

A 6 week wash out period separated the LC n-3 PUFA and the Placebo (olive oil) arms. During this period the subjects took no supplements. This arm was designed to minimise a cross-over effect.

LC n-3 PUFA Active Comparator

Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks.

Criteria 

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
No Results Posted