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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
LC n-3 PUFA (fish oil) Supplement
Sponsored by
The Adelaide and Meath Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • The Adelaide and Meath Hosptial
  • Nutrigenomics Group, University College Dublin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

LC n-3 PUFA

Placebo (olive oil) supplement

Wash out period

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 2, 2010
Last Updated
September 3, 2010
Sponsor
The Adelaide and Meath Hospital
Collaborators
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT01195155
Brief Title
Transcriptomic Profile of Adipose Tissue Following n-3 Polyunsaturated Fatty Acid (PUFA) Supplementation
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Adelaide and Meath Hospital
Collaborators
University College Dublin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LC n-3 PUFA
Arm Type
Active Comparator
Arm Description
Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks.
Arm Title
Placebo (olive oil) supplement
Arm Type
Placebo Comparator
Arm Description
4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.
Arm Title
Wash out period
Arm Type
No Intervention
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
LC n-3 PUFA (fish oil) Supplement
Other Intervention Name(s)
LC n-3 PUFA (fish oil), Placebo (PL), Wash-out (WO)
Intervention Description
4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks
Primary Outcome Measure Information:
Title
Gene expression profiling subcutaneous adipose tissue of young women with PCOS following LC n-3 PUFA supplementation versus control
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.
Time Frame
Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation
Secondary Outcome Measure Information:
Title
Assessment of biomarkers of hormonal and metabolic health in young women with PCOS following LC n-3 PUFA supplementation versus placebo
Description
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.
Time Frame
Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Gibney, Dr
Organizational Affiliation
The Adelaide and Meath Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen M Roche, Prof
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Adelaide and Meath Hosptial
City
Dublin
State/Province
Leinster
ZIP/Postal Code
Dublin 24
Country
Ireland
Facility Name
Nutrigenomics Group, University College Dublin
City
Dublin
State/Province
Leinster
ZIP/Postal Code
Dublin 4
Country
Ireland

12. IPD Sharing Statement

Learn more about this trial

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

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