Transcriptomic Profile of Adipose Tissue Following n-3 Polyunsaturated Fatty Acid (PUFA) Supplementation

Study Overview
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Brief Summary
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Adipose tissue is a central organ involved in mediating metabolic health, and so the investigation of treatments which improve adipose tissue function is warranted. LC n-3 polyunsaturated fatty acid (PUFA) have been shown to exert positive effects on adipose tissue gene expression in previous studies. However this has not been investigated in women with polycystic ovary syndrome (PCOS), a population shown to display a degree of adipose tissue dysfunction. The aim of this study was to determine the impact of LC n-3 PUFA supplementation on gene expression profiles of women with PCOS.

Official Title
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Transcriptomic Profile of Subcutaneous Adipose Tissue of Young Women With PCOS Followin 6 Weeks Supplementation With n-3 PUFA Versus Olive Oil Placebo

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: LC n-3 PUFA (fish 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: Quadruple


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: 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);|
| 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. | 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);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression profiling subcutaneous adipose tissue of young women with PCOS following LC n-3 PUFA supplementation versus control | Gene expression profiles were assessed by mircoarray analysis from samples of subcutaneous adipose tissue obtained from subjects following LC n-3 PUFA and placebo supplementation. Single gene changes and pathway analyses will be conducted to assess potential differences between PCOS and control samples. | Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of biomarkers of hormonal and metabolic health in young women with PCOS following LC n-3 PUFA supplementation versus placebo | Key biomarkers of metabolic health (plasma lipid profile, inflammatory markers and adipokines) and androgenic hormonal profile (testosterone, androstenedione, DHEAS) were assessed by measuring circulating concentrations in plasma. | Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation | 

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