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

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Dietary supplement: LC n-3 PUFA (fish oil) Supplement

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, Dublin 24
      • The Adelaide and Meath Hosptial
    • Dublin, Leinster, Ireland, Dublin 4
      • Nutrigenomics Group, University College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: LC n-3 PUFA; 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; 4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks; Other Names: LC n-3 PUFA (fish oil); Placebo (PL); Wash-out (WO)
PLACEBO_COMPARATOR: Placebo (olive oil) supplement; 4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.	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; Other Names: LC n-3 PUFA (fish oil); Placebo (PL); Wash-out (WO)
NO_INTERVENTION: Wash out period; 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; 4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks; Other Names: LC n-3 PUFA (fish oil); Placebo (PL); Wash-out (WO)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Adelaide and Meath Hospital
• Collaborators: University College Dublin

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (ESTIMATE): September 6, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 6, 2010
• Last Update Submitted That Met QC Criteria: September 3, 2010
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: PCOS
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome
• Other Study ID Numbers: DDC-UCD-ATN3