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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome
Scientific title
A Clinical Trial to Measure the Effect of DHA-enriched Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat Content in the Polycystic Ovary Syndrome
Secondary ID [1] 0 0
EC 2008/049
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Study type
Description of intervention(s) / exposure
Other interventions - Ocean Nutrition 2050
Other interventions - Olive oil capsules

Experimental: 1 - 20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.

Placebo Comparator: 2 - olive oil capsules

Other interventions: Ocean Nutrition 2050
1000mg capsules, 4 capsules/day for 8 weeks

Other interventions: Olive oil capsules
Olive oil capsules, 4 per day for 8 weeks

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
24 hour ambulatory systolic blood pressure
Timepoint [1] 0 0
week 8 and week 24
Secondary outcome [1] 0 0
24 hour heart rate variability
Timepoint [1] 0 0
week 8 and week 24
Secondary outcome [2] 0 0
liver fat content (MRI)
Timepoint [2] 0 0
week 8 and week 24

Key inclusion criteria
- Overweight/obese women with PCOS as per 1990 NIH criteria (see below)

- Non-smokers

- Age>18 years, premenopausal

- Acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia

- Acceptable to be taking the oral contraceptive pill
Minimum age
18 Years
Maximum age
50 Years
Can healthy volunteers participate?
Key exclusion criteria
- Uncontrolled hypertension (BP>160/100mmHg)

- Known co-morbidities including liver or renal disease

- Already taking fish oil supplements

- Other intercurrent illness (major surgery, CV event)

- Smokers

- Alcohol intake >20g/day

- Pregnancy

- Any metallic implant (contraindication for MRI).

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
School of Medicine and Pharmacology, Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Keogh Institute for Medical Research
Other collaborator category [1] 0 0
Name [1] 0 0
Royal Perth Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in
women with PCOS. The purpose of this study therefore is to examine the effects of fish oils
on blood pressure, heart rate variability and liver fat content in obese women with the
polycystic ovary syndrome.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Andrea J Cussons, MBBS
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications