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

NCT ID: NCT01189669

Last Updated: 2010-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

LC n-3 PUFA (fish oil) Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Placebo (olive oil) supplement

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

Group Type PLACEBO_COMPARATOR

Placebo (olive oil) supplement

Intervention Type DIETARY_SUPPLEMENT

4 x 1g olive oil capsules were given daily for 6 weeks

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo (olive oil) supplement

4 x 1g olive oil capsules were given daily for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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LC n-3 PUFA (fish oil) Placebo (PL) Wash-out (WO)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University College Dublin

OTHER

Sponsor Role collaborator

The Adelaide and Meath Hospital

OTHER

Sponsor Role lead

Responsible Party

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The Adelaide and Meath Hospital Incorporating the National Children's Hospital

Principal Investigators

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James Gibney, Dr

Role: PRINCIPAL_INVESTIGATOR

The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Helen M Roche, Prof

Role: PRINCIPAL_INVESTIGATOR

UCD

Locations

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Diabetes Day Centre, The Adelaide and Meath Hospital

Dublin, Dublin, Ireland

Site Status

Nutrigenomics Research Group, UCD

Dublin, Dublin, Ireland

Site Status

Countries

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Ireland

References

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Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26.

Reference Type DERIVED
PMID: 21270384 (View on PubMed)

Other Identifiers

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DDC-UCD-PCOS

Identifier Type: -

Identifier Source: org_study_id