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

NCT01195155 | Completed

• 1 other identifier: DDC-UCD-ATN3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Arms (3)

LC n-3 PUFA

ACTIVE COMPARATOR

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

Placebo (olive oil) supplement

PLACEBO COMPARATOR

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

Dietary Supplement: LC n-3 PUFA (fish oil) Supplement

Wash out period

NO INTERVENTION

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

Interventions

LC n-3 PUFA (fish oil) Supplement DIETARY_SUPPLEMENT

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

Also known as: LC n-3 PUFA (fish oil), Placebo (PL), Wash-out (WO)

LC n-3 PUFA; Placebo (olive oil) supplement; Wash out period

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Adelaide and Meath Hospital: lead
• University College Dublin: collaborator

Study Sites (2)

The Adelaide and Meath Hosptial

Dublin, Leinster, Dublin 24, Ireland

Location

Nutrigenomics Group, University College Dublin

Dublin, Leinster, Dublin 4, Ireland

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• James Gibney, Dr

  The Adelaide and Meath Hospital

  PRINCIPAL INVESTIGATOR

• Helen M Roche, Prof

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 6, 2010
• Study Start: December 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 6, 2010

Record last verified: 2008-07

Locations

IE (2)