Mechanism of cardiovascular benefits of omega-3 fatty acids in hypertensive and normotensive subjects

Double-blinded, placebo controlled investigation of the cardiovascular benefits of omega-3 fatty acids in hypertensive and normotensive subjects

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000713099

Enrollment

140

Registered

2010-08-27

Start date

2010-09-06

Completion date

Unknown

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

This study is testing the hypothesis that improvements in cardiovascular health with omega-3 fatty acid supplements are attributed to improvements in vascular function.

Interventions

Normotensive and Hypertensive subjects will receive 4x1 g placebo capsules/day (Sunola oil) for 3 weeks. Subjects will then be randomised to receive either 4x1g fish oil capsules/day (Blackmores Omega Heart, Blackmores Ltd, Australia) containing 2.52 g/day eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA), or 4x1g placebo capsules/day for 12 weeks. A final 3 week washout phase will follow in which subjects cease taking the capsules. Subjects will record daily blood pressure (BP) at home using an automated BP device for the 18 week trial. Fasted blood samples will be taken every three weeks, commencing at week 0. Subjects will undergo a cold pressor test, a hand grip test, and reactive hyperaemic response with measurements of BP, blood flow and heart rate variability at weeks 1, 3 and then at 3 weekly intervals.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

30 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

Men or women with normal BP, or mild hypertension (140-159/90-99 mmHg). Subjects consume no more than 2 oily fish meals per week.

Exclusion criteria

Subjects are not eligible to participate if they are currently taking medication to lower their blood pressure, are on a special diet eg. Atkins diet, Lo-Carbo diet and Zone diet, or have a high level of daily exercise. Other exclusions: unable to communicate in English, pregnant, infectious disease eg. human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), hepatitis.

Outcome results