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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189669
• Other study ID #: DDC-UCD-PCOS
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: September 10, 2010
• Start date: September 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: The Adelaide and Meath Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Ireland	Diabetes Day Centre, The Adelaide and Meath Hospital	Dublin
Ireland	Nutrigenomics Research Group, UCD	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
The Adelaide and Meath Hospital	University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting lipid metabolism		Following supplementation with LCn-3 PUFA or placebo for 6 weeks	No
Secondary	Plasma hormonal profile		Following supplementation with LCn-3PUFA or placebo for 6 weeks	No
Secondary	Postprandial lipid metabolism		Following supplementation with LCn-3 PUFA or placebo for 6 weeks	No