Transcriptomic Profile of Subcutaneous Adipose Tissue of Young Women With PCOS Followin 6 Weeks Supplementation With n-3 PUFA Versus Olive Oil Placebo
18 Years
40 Years
Female
Polycystic Ovary Syndrome
Trial Information
Transcriptomic Profile of Subcutaneous Adipose Tissue of Young Women With PCOS Followin 6 Weeks Supplementation With n-3 PUFA Versus Olive Oil Placebo
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Gene expression profiling subcutaneous adipose tissue of young women with PCOS following LC n-3 PUFA supplementation versus control
Outcome Description:
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.
Outcome Time Frame:
Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation
Safety Issue:
No
Principal Investigator
James Gibney, Dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Adelaide and Meath Hospital
Authority:
Ireland: Research Ethics Committee
Study ID:
DDC-UCD-ATN3
NCT ID:
NCT01195155
Start Date:
December 2007
Completion Date:
July 2008
Related Keywords:
- Polycystic Ovary Syndrome
- PCOS
- Polycystic Ovary Syndrome
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