High-normal blood pressure stage I hypertension
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| The main study parameter is the change in 24h-ambulatory mean arterial pressure (MAP) | — |
Secondary
| Measure | Time 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