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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195155
• Other study ID #: DDC-UCD-ATN3
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: September 3, 2010
• Start date: December 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: The Adelaide and Meath Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• LC n-3 PUFA (fish oil) Supplement
4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks

Locations

Country	Name	City	State
Ireland	Nutrigenomics Group, University College Dublin	Dublin	Leinster
Ireland	The Adelaide and Meath Hosptial	Dublin	Leinster

Sponsors (2)

Lead Sponsor	Collaborator
The Adelaide and Meath Hospital	University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No