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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: LC n-3 PUFA (fish oil) Supplement
* Dietary Supplement: Placebo (olive oil) supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LC n-3 PUFA<br>Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks. | Dietary Supplement: LC n-3 PUFA (fish oil) Supplement<br>* 4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks<br>* Other names: Wash-out (WO);|
| Placebo Comparator: Placebo (olive oil) supplement<br>4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks. | Dietary Supplement: Placebo (olive oil) supplement<br>* 4 x 1g olive oil capsules were given daily for 6 weeks<br>|
| No Intervention: Wash out period<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting lipid metabolism |  | Following supplementation with LCn-3 PUFA or placebo for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS