To study the effects of echium oil, rich in SDA on serum triacylglycerol concentrations in healthy overweight and slightly obese men and women. The minor objective is to study the effects of echium oil on the omega-3 index, which is negatively…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The main study parameter is the change is
fasting serum triacylglycerol concentrations.
Secondary outcome
The secondary endpoint is the change in the omega-3 index.
Background summary
Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation
can reduce the risk for coronary heart disease. EPA can be synthesized from α-
linolenic acid (ALA or C18:3n-3), but conversion is low. It has been suggested
that the rate-limiting step for this conversion is the Δ6-desaturation of ALA
into stearidonic acid (SDA or C18:4n-3). Thus, providing oils rich in SDA may
increase the endogenous synthesis of EPA. This may subsequently lower serum
triacylglycerol concentrations, an effect frequently observed after EPA
supplementation, especially in people with increased triacylglycerol levels.
Study objective
To study the effects of echium oil, rich in SDA on serum triacylglycerol
concentrations in healthy overweight and slightly obese men and women. The
minor objective is to study the effects of echium oil on the omega-3 index,
which is negatively related to cardiovascular risk and defined as the
proportion of EPA and DHA in red blood cells.
Study design
Using a randomized, double-blind, placebo controlled crossover design, subjects
will receive in random order for six weeks with a washout period of at least 14
days, daily 10 mL of echium oil or a high-oleic acid sunflower oil (HOSO) as
control.
Intervention
During the experimental period, subjects will receive daily one sachet at lunch
and one sachet at dinner each providing 5 g of echium oil. During the control
period, subjects will receive daily at the same time points sachets with the
same amount of HOSO.
Study burden and risks
Before the start of the study subjects will be screened to determine
eligibility during one 15 and one 10 min visit. During these visits, body
weight, height and blood pressure will be measured and a blood sample (4.5 mL)
will be drawn by means of venapunction. During the study, subjects will receive
the echium and control in random order. At weeks 1, 3, 5 and 6 of each 6 wk
period, a fasting blood sample will be drawn (10 mL, 20 mL and 2 x 30 mL). In
addition, during week 6 of each intervention period, a retinal image will be
taken and pulse wave velocity measurements will be performed to assess vascular
function. Subjects will be asked to fill out a food frequency questionnaire two
times and to keep a study-diary throughout study. On rare occasions, blood
sampling might cause bruises or hematoma. Total time investment for the
subjects will be approximately 6 hours.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
- aged between 18-70 years
- Quetelet-index between 25-35 kg/m2
- mean serum triacylglycerol < 3.0 mmol/L
Exclusion criteria
- unstable body weight (weight gain or loss >2 kg in the past 3 months)
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication or a diet known to affect serum lipid or glucose metabolism
- 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 epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis
- abuse of drugs
- more than 21 alcohol consumptions per week for men and 14 consumptions for women
- not 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01365078 |
| CCMO | NL36654.068.11 |