Status:
COMPLETED
Alpha-linolenic Acid and Blood Pressure
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Unilever R&D
Conditions:
Hypertension
Lipid Metabolism Disorders
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Quetelet-index between 25-35 kg/m2
- High-normal blood pressure defined as systolic blood pressure between 130-139 mmHg and/or diastolic blood pressure between 85-89 mmHg. Or stage I hypertension defined as systolic blood pressure between 140-159 mmHg and/or diastolic blood pressure between 90-99 mmHg.
- Mean serum total cholesterol/HDL cholesterol ratio \< 8
- Mean serum triacylglycerol \< 4.5 mmol/L
- Mean plasma glucose \< 7.0 mmol/L
Exclusion
- Unstable body weight (weight gain or loss \>2 kg in the past 3 months)
- Use of antihypertensive or anticoagulant medication
- Indication for treatment with medication according to the Standard for cardiovascular risk management of the Dutch general practitioners community (NHG)
- Usage of non-steroidal anti-inflammatory drugs (such as 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 with expected changes in the use of oral contraceptives or estrogen replacement therapy during the study period
- 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 or recently quit smoking (\<1 years)
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02243969
Start Date
May 1 2014
End Date
October 1 2015
Last Update
March 22 2016
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 ER