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

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ClinicalTrials.gov Identifier: NCT01189669
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : September 13, 2010
Sponsor:
Collaborator:
University College Dublin
Information provided by:
The Adelaide and Meath Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Dietary Supplement: LC n-3 PUFA (fish oil) Supplement Dietary Supplement: Placebo (olive oil) supplement Not Applicable

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  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008


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.



Primary Outcome Measures :
  1. Fasting lipid metabolism [ Time Frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks ]

Secondary Outcome Measures :
  1. Plasma hormonal profile [ Time Frame: Following supplementation with LCn-3PUFA or placebo for 6 weeks ]
  2. Postprandial lipid metabolism [ Time Frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189669


Locations
Ireland
Diabetes Day Centre, The Adelaide and Meath Hospital
Dublin, Ireland, 24
Nutrigenomics Research Group, UCD
Dublin, Ireland, 4
Sponsors and Collaborators
The Adelaide and Meath Hospital
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr James Gibney, The Adelaide and Meath Hospital Incorporating the National Children's Hospital
ClinicalTrials.gov Identifier: NCT01189669     History of Changes
Other Study ID Numbers: DDC-UCD-PCOS
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: July 2008

Keywords provided by The Adelaide and Meath Hospital:
PCOS

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