Alpha-linolenic Acid and Blood Pressure

Summary

Rationale: Increased intakes of n-3 long chain polyunsaturated fatty acids eicosapentanoic acid (EPA) and docosahexaenoic acid (DHA), mainly found in fatty fish, are recommended for the prevention of coronary heart disease. Alpha-linolenic acid (ALA, C18:3n-3) is the most common vegetable-oil based n-3 fatty acid. Evidence exists that ALA supplementation can also have a protective effect on the development on cardiovascular disease, but may exert its cardio protective effects through different routes. The benefit may (partly) be due to blood pressure lowering. However, evidence for beneficial effects of ALA on blood pressure is conflicting. Therefore, we propose to investigate the effect of flaxseed oil, high in ALA, using a study powered on 24-hour blood pressure, in a population with high normal blood pressure and mild hypertension.

Objective: To study the effects of flaxseed oil, rich in ALA on 24h-ambulatory mean arterial pressure (MAP) in men and women with high-normal blood pressure and mild hypertension compared to high oleic sunflower oil, poor in ALA.

Study design: Using a double blind randomized, placebo-controlled parallel design, subjects will receive at random daily 10 g of flaxseed oil or a high-oleic acid sunflower oil (HOSF) as control for twelve weeks, with a run-in period of 14 days in advance.

Study population: 72 men and women, aged 40-70 years, with untreated high-normal blood pressure and stage I hypertension and a body mass index between 25 and 35 kg/m2 will participate in the run-in and intervention period. It is estimated that 144 subject have to be screened to find 72 subjects that will enter the run-in period.

Intervention: During the run-in period, subjects will receive daily 10 g of palm super olein oil. During the intervention period subjects receive either 10 g of HOSF or flaxseed oil. All oils are provided in bottles of 5 g, one will be consumed at breakfast or lunch and one at dinner.

Main study parameters/endpoints: The main study parameter is the change in 24h-ambulatory mean arterial pressure (MAP)

Conditions

• Hypertension
• Lipid Metabolism Disorders

Interventions

DIETARY_SUPPLEMENT

Flaxseed oil

The flaxseed oil will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day

DIETARY_SUPPLEMENT

high oleic sunflower oil (HOSF)

The HOSF will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day

Sponsors & Collaborators

• Unilever R&D

  collaborator INDUSTRY

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Ronald P Mensink, PhD · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2015-10-31

Completion

2015-10-31

Countries

• Netherlands

Study Locations