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Effects of alpha-linolenic acid on 24h-ambulatory mean arterial pressure in untreated high-normal and stage I hypertensive subjects

Effects of alpha-linolenic acid on 24h-ambulatory mean arterial pressure in untreated high-normal and stage I hypertensive subjects - VASALA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40127
Enrollment
144
Registered
2014-04-16
Start date
2014-06-19
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

High-normal blood pressure stage I hypertension

Interventions

During the run-in period, subjects will receive daily 10 g of palm super olein oil. During the intervention period subjects receive either 10 ml of high oleic sunflower oil or flaxseed oil. All oils

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Aged between 40-70 years - Quetelet-index between 25-35 kg/m2 - High-normal blood pressure or stage I hypertension - Mean serum total cholesterol

Exclusion criteria

Exclusion criteria: - Unstable body weight (weight gain or loss >2 kg in the past 3 months) - Use of antihypertensive or anticoagulant medication - Indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus - Usage of non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study - Use of medication or a diet known to affect serum lipid or glucose metabolism - Women taking oral contraceptives or estrogen replacement therapy - Women lactating, pregnant or intend to become pregnant during study - Active cardiovascular disease like congestive heart failure or recent ( 10 h/w - Not possible or difficult to venipuncture as evidenced during the screening visits - Use of an investigational product within the previous 30 days - Not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study - Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study

Design outcomes

Primary

MeasureTime frame
The main study parameter is the change in 24h-ambulatory mean arterial pressure (MAP)

Secondary

MeasureTime frame
The secondary objectives are to study the effects of flaxseed oil on 1) night, day and early morning 24h-ambulatory MAP, 2) systolic, diastolic and MAP office blood pressure, 3) postprandial flow mediated dilatation (FMD) and 4) the fatty-acid profile of plasma phospholipids

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)