n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)

September 10, 2010 updated by: The Adelaide and Meath Hospital

Long Chain (LC) n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS): A Cross-over, Placebo Controlled Dietary Intervention Study

This is a dietary intervention study designed to assess the impact of long chain (LC) n-3 polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS). Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Polycystic ovary syndrome (PCOS) is a chronic condition affecting young women of reproductive age. Long-term, safe and efficacious treatments are needed for women with this condition, and dietary therapy may have an important role in its treatment. LC n-3 PUFA have been shown to be potent biological regulators, involved in the amelioration of many of the adverse metabolic risk factors which are often present in women with PCOS. The aim of this study was to explore the impact of LC n-3 PUFA on fasting and post-prandial lipid metabolism, as well as on the hormonal profile of women with PCOS.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 24
        • Diabetes Day Centre, The Adelaide and Meath Hospital
      • Dublin, Ireland, 4
        • Nutrigenomics Research Group, UCD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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: Placebo (olive oil) supplement
4 x 1g olive oil capsules were given daily for 6 weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting lipid metabolism
Time Frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Following supplementation with LCn-3 PUFA or placebo for 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma hormonal profile
Time Frame: Following supplementation with LCn-3PUFA or placebo for 6 weeks
Following supplementation with LCn-3PUFA or placebo for 6 weeks
Postprandial lipid metabolism
Time Frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Following supplementation with LCn-3 PUFA or placebo for 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Adelaide and Meath Hospital

Collaborators

University College Dublin

Investigators

  • Principal Investigator: James Gibney, Dr, The Adelaide and Meath Hospital, incorporating The National Children's Hospital
  • Principal Investigator: Helen M Roche, Prof, UCD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (ESTIMATE)

August 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDC-UCD-PCOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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