Comparison of blood levels of factors involved in resolving inflammation in individuals with features of the metabolic syndrome versus matched healthy controls

Measurement of anti-inflammatory resolvins and protectins in individuals with features of the metabolic syndrome compared with matched healthy controls, after omega-3 fatty acids alone and in combination with aspirin

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000708055

Acronym

OARS-2

Enrollment

Registered

2010-08-25

Start date

2010-10-11

Completion date

2011-08-26

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The hypothesis is that in humans dietary omega-3 fatty acids and aspirin augment the formation of the potent anti-inflammatory metabolites resolvins and protectins. We aim to measure resolvin and protectin levels in individuals with features of the metabolic syndrome compared with matched healthy controls, after omega-3 fatty acids alone and in combination with aspirin;

Interventions

20 men and women with features of the metabolic syndrome and 20 age and gender matched healthy controls will enter a 4 week trial of parallel design. All participants will be asked to take 4 x 1g fish oil capsules daily (Omega Daily, Blackmores Ltd, Australia) supplying approximately 2.4g/day of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA), for 4 weeks. They will be asked to take 300mg aspirin/day in addition to the fish oil, during the last (4th) week. fish oil capsules and aspirin

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Men and post-menopausal women not taking hormone replacement therapy, aged 20-70 years, will be recruited from the general population by newspaper advertisements. Subjects will recruited on the basis of being untreated but having features of the metabolic syndrome using the criteria of the National Cholesterol Education Program Adult Treatment Panel III (NCEP: ATP III). They will be invited to participate if they have a waist circumference >102cm for males and >88cm for females and systolic blood pressure (SBP) >130 mmHg, Age and gender matched healthy control subjects will be recruited from the general population. Subjects will be included if in the age range 20 to 70 years with a waist circumference <102cm for males and <88cm for females and no other defining criteria for the metabolic syndrome.

Exclusion criteria

Smokers, history of cardiovascular or peripheral vascular disease, diabetes, renal disease, liver disease or taking anti-hypertensive agents, lipid lowering drugs, aspirin or non-steroidal anti-inflammatory drugs, omega-3 fatty acids or >2 fish meals /week.

Outcome results