Clinical trial NCT01189669: n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Lead sponsor: The Adelaide and Meath Hospital
Sponsor class: OTHER
Collaborators: name: University College Dublin
First posted: 2010-08-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Fasting lipid metabolism
timeFrame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Secondary outcomes:
measure: Plasma hormonal profile
timeFrame: Following supplementation with LCn-3PUFA or placebo for 6 weeks
measure: Postprandial lipid metabolism
timeFrame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Diabetes Day Centre, The Adelaide and Meath Hospital
city: Dublin
country: Ireland
facility: Nutrigenomics Research Group, UCD
Study officials:
affiliation: The Adelaide and Meath Hospital, incorporating The National Children's Hospital
name: James Gibney, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: UCD
name: Helen M Roche, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26.