Hypertension Clinical Trial
Official title:
Effects of Alpha-linolenic Acid on 24h-ambulatory Mean Arterial Pressure in Untreated High-normal and Stage I Hypertensive Subjects
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)
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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