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

The Adelaide and Meath Hospital

Status: Completed

Conditions: Polycystic Ovary Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01195155

DDC-UCD-ATN3

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 3 patient groups, including a placebo group

LC n-3 PUFA

Active Comparator group

Description:

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

Treatment:

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

Placebo (olive oil) supplement

Placebo Comparator group

Description:

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

Treatment:

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

Wash out period

No Intervention group

Description:

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.

Treatment:

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