Not Yet RecruitingPhase 3ACTRN12610000713099

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

Sponsor

University of the Sunshine Coast

Enrollment

140 participants

Start Date

Sep 6, 2010

Study Type

Interventional

Conditions

Hypertensive men and women

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.

Eligibility

Sex: Both males and femalesMin Age: 30 YearssMax Age: 85 Yearss

Inclusion Criteria1

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 Criteria1

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.

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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 Omeg

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.

Locations(1)

Australia

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ACTRN12610000713099