Back to resultsAlpha-linolenic Acid and Blood Pressure (VASALA)
Primary Purpose
Hypertension, Lipid Metabolism Disorders
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Flaxseed oil
high oleic sunflower oil (HOSF)
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring n-3 polyunsaturated fatty acids, Alpha-linolenic acid, Blood pressure, Vascular function
Eligibility Criteria
Inclusion Criteria:
- 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 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 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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
flaxseed oil (rich in α-linolenic acid )
high oleic sunflower oil
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
The fatty-acid profile of plasma phospholipids
measured in fasting plasma samples
Full Information
NCT ID
NCT02243969
First Posted
May 19, 2014
Last Updated
March 21, 2016
Sponsor
Maastricht University Medical Center
Collaborators
Unilever R&D
1. Study Identification
Unique Protocol Identification Number
NCT02243969
Brief Title
Alpha-linolenic Acid and Blood Pressure
Acronym
VASALA
Official Title
Effects of Alpha-linolenic Acid on 24h-ambulatory Mean Arterial Pressure in Untreated High-normal and Stage I Hypertensive Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Unilever R&D
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Lipid Metabolism Disorders
Keywords
n-3 polyunsaturated fatty acids, Alpha-linolenic acid, Blood pressure, Vascular function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
flaxseed oil (rich in α-linolenic acid )
Arm Type
Experimental
Arm Title
high oleic sunflower oil
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Flaxseed oil
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
high oleic sunflower oil (HOSF)
Intervention Description
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
Primary Outcome Measure Information:
Title
24h-ambulatory mean arterial pressure (MAP)
Description
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.
Time Frame
Baseline and end of intervention period (week 2 and 14)
Secondary Outcome Measure Information:
Title
Postprandial flow mediated dilatation (FMD)
Description
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.
Time Frame
End of intervention period (week 14)
Title
Night, day and early morning 24h-ambulatory MAP, SBP and DBP
Description
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.
Time Frame
Baseline and end of intervention (week 2 and 14)
Title
Systolic, diastolic and MAP office blood pressure
Description
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.
Time Frame
Measured every visit (week 1,2,8,14)
Title
The fatty-acid profile of plasma phospholipids
Description
measured in fasting plasma samples
Time Frame
Baseline and end of intervention period (week 2 and 14)
Other Pre-specified Outcome Measures:
Title
Pulse wave velocity (PWV)
Description
PWV will be determined by extending data from standard brachial artery blood pressure measurements
Time Frame
Baseline and end of intervention period (week 2 and 14)
Title
Retinal microvasculature
Description
Measured as AV-ratio and vessel diameter from digitized analogue fundus photographs
Time Frame
Baseline and end of intervention period (week 2 and 14)
Title
Fasting and postprandial lipid and glucose metabolism
Description
Postprandial glucose at time point 15,30,45,60,90,120,180,240 minutes Postprandial lipids at time point 60, 120, 180, 240 minutes
Time Frame
Every visit (week 1,2,8,14) Postprandial in subset of n=20 per group
Title
Fasting and postprandial serum biomarkers for low-grade systemic inflammation (hsCRP, IL-6) and endothelial function (sICAM-1, VCAM-1, MCP-1 and sE-Selectin)
Time Frame
Every visit (week 1,2,8,14) Postprandial in subset of n=20 per group at time point 60, 120, 240 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 ER
Country
Netherlands
12. IPD Sharing Statement
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Alpha-linolenic Acid and Blood Pressure
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