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

Completed

• Conditions: High-normal blood pressure; stage I hypertension; 10013317; 10057166

• Registration Number: NL-OMON40127
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 144

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 < 8.0 mmol/L
- Mean serum triacylglycerol < 4.5 mmol/L
- Mean plasma glucose < 7.0 mmol/L

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 (<6 months) event (acute myocardial infarction, cerebro vascular accident)
- Severe medical conditions that might interfere with the study such as diabetes mellitus, epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis
- Smoking
- Abuse of drugs
- More than 21 alcohol consumptions per week for men and 14 consumptions for women
- Reported intense sporting activities > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in 24h-ambulatory mean arterial pressure<br /><br>(MAP)</p><br>

Secondary Outcome Measures

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