Skip to main content
Clinical Trials/NCT01195155
NCT01195155
Completed
Not Applicable

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

The Adelaide and Meath Hospital2 sites in 1 country10 target enrollmentDecember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polycystic Ovary Syndrome
Sponsor
The Adelaide and Meath Hospital
Enrollment
10
Locations
2
Primary Endpoint
Gene expression profiling subcutaneous adipose tissue of young women with PCOS following LC n-3 PUFA supplementation versus control
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
July 2008
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
The Adelaide and Meath Hospital

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

Outcomes

Primary Outcomes

Gene expression profiling subcutaneous adipose tissue of young women with PCOS following LC n-3 PUFA supplementation versus control

Time Frame: Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation

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.

Secondary Outcomes

  • Assessment of biomarkers of hormonal and metabolic health in young women with PCOS following LC n-3 PUFA supplementation versus placebo(Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation)

Study Sites (2)

Loading locations...

Similar Trials