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

This study has been completed.
Sponsor:
Collaborator:
University College Dublin
Information provided by:
The Adelaide and Meath Hospital
ClinicalTrials.gov Identifier:
NCT01195155
First received: September 2, 2010
Last updated: September 3, 2010
Last verified: July 2008
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Dietary Supplement: LC n-3 PUFA (fish oil) Supplement

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

Resource links provided by NLM:


Further study details as provided by The Adelaide and Meath Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Following 6 weeks of LC n-3 PUFA supplementation versus 6 weeks olive oil placebo supplementation ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: December 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195155

Locations
Ireland
Nutrigenomics Group, University College Dublin
Dublin, Leinster, Ireland, Dublin 4
The Adelaide and Meath Hosptial
Dublin, Leinster, Ireland, Dublin 24
Sponsors and Collaborators
The Adelaide and Meath Hospital
University College Dublin
Investigators
Principal Investigator: James Gibney, Dr The Adelaide and Meath Hospital
Principal Investigator: Helen M Roche, Prof University College Dublin
  More Information

No publications provided

Responsible Party: Dr James Gibney, The Adelaide and Meath Hospital Incorporating the National Children's Hospital
ClinicalTrials.gov Identifier: NCT01195155     History of Changes
Other Study ID Numbers: DDC-UCD-ATN3
Study First Received: September 2, 2010
Last Updated: September 3, 2010
Health Authority: Ireland: Research Ethics Committee

Keywords provided by The Adelaide and Meath Hospital:
PCOS

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Adnexal Diseases
Cysts
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases

ClinicalTrials.gov processed this record on November 27, 2014