Back to resultsn-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
LC n-3 PUFA (fish oil) Supplement
Placebo (olive oil) supplement
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS
Eligibility 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
Sites / Locations
- Diabetes Day Centre, The Adelaide and Meath Hospital
- Nutrigenomics Research Group, UCD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
LC n-3 PUFA
Placebo (olive oil) supplement
Wash out period
Arm Description
Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks.
4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.
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.
Outcomes
Primary Outcome Measures
Fasting lipid metabolism
Secondary Outcome Measures
Plasma hormonal profile
Postprandial lipid metabolism
Full Information
NCT ID
NCT01189669
First Posted
August 24, 2010
Last Updated
September 10, 2010
Sponsor
The Adelaide and Meath Hospital
Collaborators
University College Dublin
1. Study Identification
Unique Protocol Identification Number
NCT01189669
Brief Title
n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Adelaide and Meath Hospital
Collaborators
University College Dublin
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LC n-3 PUFA
Arm Type
Active Comparator
Arm Description
Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks.
Arm Title
Placebo (olive oil) supplement
Arm Type
Placebo Comparator
Arm Description
4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks.
Arm Title
Wash out period
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
LC n-3 PUFA (fish oil) Supplement
Other Intervention Name(s)
LC n-3 PUFA (fish oil), Placebo (PL), Wash-out (WO)
Intervention Description
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
Intervention Name(s)
Placebo (olive oil) supplement
Intervention Description
4 x 1g olive oil capsules were given daily for 6 weeks
Primary Outcome Measure Information:
Title
Fasting lipid metabolism
Time Frame
Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Secondary Outcome Measure Information:
Title
Plasma hormonal profile
Time Frame
Following supplementation with LCn-3PUFA or placebo for 6 weeks
Title
Postprandial lipid metabolism
Time Frame
Following supplementation with LCn-3 PUFA or placebo for 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Gibney, Dr
Organizational Affiliation
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen M Roche, Prof
Organizational Affiliation
UCD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Day Centre, The Adelaide and Meath Hospital
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
Nutrigenomics Research Group, UCD
City
Dublin
ZIP/Postal Code
4
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21270384
Citation
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.
Results Reference
derived
Learn more about this trial
n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
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