n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
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
1 other identifier
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2007
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 24, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedSeptember 13, 2010
July 1, 2008
10 months
August 24, 2010
September 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting lipid metabolism
Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Secondary Outcomes (2)
Plasma hormonal profile
Following supplementation with LCn-3PUFA or placebo for 6 weeks
Postprandial lipid metabolism
Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Study Arms (3)
LC n-3 PUFA
ACTIVE COMPARATORSupplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks.
Placebo (olive oil) supplement
PLACEBO COMPARATOR4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.
Wash out period
NO INTERVENTIONA 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.
Interventions
4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks
4 x 1g olive oil capsules were given daily for 6 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Adelaide and Meath Hospitallead
- University College Dublincollaborator
Study Sites (2)
Diabetes Day Centre, The Adelaide and Meath Hospital
Dublin, Dublin, 24, Ireland
Nutrigenomics Research Group, UCD
Dublin, Dublin, 4, Ireland
Related Publications (1)
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.
PMID: 21270384DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Gibney, Dr
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
- PRINCIPAL INVESTIGATOR
Helen M Roche, Prof
UCD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 24, 2010
First Posted
August 27, 2010
Study Start
September 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
September 13, 2010
Record last verified: 2008-07