The objective of this study is to investigate the effect 8-week OLECOL supplementation on cardiovascular risk markers.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Risicofactoren voor cardiovasculaire ziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficady parameter is blood lipid profile, as assesed by blood
levels of total cholesterol, HDL and LDL cholesterol and triglycerides.
Secondary outcome
Secondary objectives include the assessment of the effect of OLECOL on lipid
peroxidation, platelet aggregation, advanced glycation end-products, blood
pressure, liver function, glucose and insulin metabolism, intestinal
inflammation, metabolic activity, microbiota composition, and gastrointestinal
symptoms.
Background summary
Cardiovascular disease (CVD) is the leading cause of death in Europe. Although
the mortality of CVD is decreasing lately, the burden of CVD morbidity, tracked
by hospital discharge data, has tended to trend upward since the early 2000s.
Current guidelines emphasize lifestyle recommendations to prevent the incidence
of CVD, such as increasing physical activity and reducing weight in overweight
and obese. However, medicines are needed if lifestyle changes are not enough.
Nevertheless, the high costs and side effects of these drugs highlight the need
for new cost-effective primary preventive measures to reduce the incidence of
CVD.
Supplementation with OLECOL, an olive leaf extract standardized for its
oleuropein content (>16%) may have beneficial effects on multiple biomarkers of
CVD; a link between polyphenol intake and the improvement of lipid profiles,
protection from low density lipoprotein (LDL) oxidation, atherosclerotic
progression, hypertension, inflammation and endothelial dysfunction has been
proposed. Furthermore, it will be determined whether a link between the
supplement intake and nonalcoholic fatty liver disease (NAFLD), glucose/insulin
levels and intestinal inflammation and microbiota composition can be detected.
Study objective
The objective of this study is to investigate the effect 8-week OLECOL
supplementation on cardiovascular risk markers.
Study design
This is a randomized, parallel, double-blind, placebo-controlled trial.
Intervention
Participants will receive a daily dose of OLECOL or placebo for a period of 8
weeks. Two capsules of OLECOL or placebo have to be ingested every day 30
minutes before the first meal with a glass of water.
Study burden and risks
There are different burdens volunteers can experience during the study. Burdens
that volunteers can experience are the time spend on the study (subjects will
have to invest approximately 6 hours in the study). Subjects will have to take
OLECOL or placebo supplements once daily for a period of 8 weeks; the
supplements are safe for human use. They have to follow a dietary and healthy
regimen, and cannot use alcohol and abstain from physical exercise prior to the
test days. Also, they will have to discuss their medical history with the
investigator, fill in three times a 3-day food record and a maximum total of
234 mL blood will be sampled during the three study visits by venipuncture.
This may lead to minor discomfort and can cause small and transitory
hematoma/bruises to appear.
universiteitssingel 40
Maastricht 6229ER
NL
universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
Healthy individuals, Age: 18-70 years, BMI 25-35 kg/m2, Total cholesterol levels * 5.0 mmol/L.
Exclusion criteria
* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
* Diabetes
* Use of medication that might have influence on endpoints (e.g. cholesterol lowering medication, hypertensive medication)
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to this study
* Use of antibiotics in the 30 days prior to the start of the study
* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
* Pregnancy, lactation
* Abuse of products (> 20 alcoholic consumptions per week and drugs)
* Smoking
* Weight gain or loss (> 3 kg in previous 3 months)
* High physical activity (>4.5 hours of running/week)
* History of any side effects towards intake of olives
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 |
|---|---|
| CCMO | NL54513.068.15 |
| Other | volgt, registratie bij clinicaltrials.gov |