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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


N/A
18 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Fasting lipid metabolism

Outcome Time Frame:

Following supplementation with LCn-3 PUFA or placebo for 6 weeks

Safety Issue:

No

Principal Investigator

James Gibney, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Ireland: Research Ethics Committee

Study ID:

DDC-UCD-PCOS

NCT ID:

NCT01189669

Start Date:

September 2007

Completion Date:

July 2008

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Polycystic Ovary Syndrome

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