HypertensionVASALANCT02243969
Alpha-linolenic Acid and Blood Pressure
A study testing Flaxseed oil and high oleic sunflower oil (HOSF) in people with Hypertension and Lipid Metabolism Disorders, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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 coronary heart disease. Alpha-linolenic acid (ALA, C18:3n-3) is the most common vegetable-oil based n-3 fatty acid. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Lipid Metabolism Disorders
- What is being tested?
- Flaxseed oil and high oleic sunflower oil (HOSF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 ER
About this study
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.
Read more
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)
- Conditions
- Hypertension, Lipid Metabolism Disorders
- Being tested
- Flaxseed oil, high oleic sunflower oil (HOSF)
- Keywords
- n-3 polyunsaturated fatty acids, Alpha-linolenic acid, Blood pressure, Vascular function
- Medical subject headings
- Hypertension, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaxseed oilDietary supplement
The flaxseed oil will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day
high oleic sunflower oil (HOSF)Dietary supplement
The HOSF will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day
| Study group | Role | What they receive |
|---|---|---|
| flaxseed oil (rich in α-linolenic acid ) | Experimental | Not described Receives: Dietary Supplement: Flaxseed oil |
| high oleic sunflower oil | Placebo comparator | Not described Receives: Dietary Supplement: high oleic sunflower oil (HOSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h-ambulatory mean arterial pressure (MAP)
Ambulatory blood pressure measurements will be performed using an automated blood pressure device with 15-minute intervals during the day and 30-minute intervals during the night.
Measured: Baseline and end of intervention period (week 2 and 14)
Secondary outcomes (4)
Postprandial flow mediated dilatation (FMD)
The brachial artery FMD will be measured in a subset (n=20 per group) of the study population. FMD will be measured before and 2 hours after a fat load.
Measured: End of intervention period (week 14)
Night, day and early morning 24h-ambulatory MAP, SBP and DBP
Ambulatory blood pressure measurements will be performed using an automated blood pressure device with 15-minute intervals during the day and 30-minute intervals during the night.
Measured: Baseline and end of intervention (week 2 and 14)
Systolic, diastolic and MAP office blood pressure
Each visit blood pressure will be measured in four-fold with 1-minute interval (the first measurement will be discarded and the last three measurement will be averaged) using a calibrated device.
Measured: Measured every visit (week 1,2,8,14)
The fatty-acid profile of plasma phospholipids
measured in fasting plasma samples
Measured: Baseline and end of intervention period (week 2 and 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243969
- Sponsor's protocol ID
- MEC 13-3-064
- Acronym
- VASALA
- Status last verified
- Sep 2015
- First submitted
- 19 May 2014
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alpha-linolenic Acid on 24h-ambulatory Mean Arterial Pressure in Untreated High-normal and Stage I Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT02243969
- Acronym / sponsor ID
- VASALA / MEC 13-3-064
- Conditions
- Hypertension, Lipid Metabolism Disorders
- Keywords
- n-3 polyunsaturated fatty acids, Alpha-linolenic acid, Blood pressure, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flaxseed oil (rich in α-linolenic acid ) | Experimental | Dietary Supplement: Flaxseed oil |
| high oleic sunflower oil | Placebo comparator | Dietary Supplement: high oleic sunflower oil (HOSF) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flaxseed oilThe flaxseed oil will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day | Dietary supplement | flaxseed oil (rich in α-linolenic acid ) |
| high oleic sunflower oil (HOSF)The HOSF will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day | Dietary supplement | high oleic sunflower oil |
Primary outcome
24h-ambulatory mean arterial pressure (MAP)
Time frame: Baseline and end of intervention period (week 2 and 14)
Ambulatory blood pressure measurements will be performed using an automated blood pressure device with 15-minute intervals during the day and 30-minute intervals during the night.
4 secondary outcomes
Postprandial flow mediated dilatation (FMD)
Time frame: End of intervention period (week 14)
Night, day and early morning 24h-ambulatory MAP, SBP and DBP
Time frame: Baseline and end of intervention (week 2 and 14)
Systolic, diastolic and MAP office blood pressure
Time frame: Measured every visit (week 1,2,8,14)
The fatty-acid profile of plasma phospholipids
Time frame: Baseline and end of intervention period (week 2 and 14)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald P Mensink, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed oil and high oleic sunflower oil (HOSF) in people with Hypertension and Lipid Metabolism Disorders, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h-ambulatory mean arterial pressure (MAP) (time frame: Baseline and end of intervention period (week 2 and 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.