Overweight and ObesityNCT02990637
The Effect of Olive Leaf Extract Administration on Cardiovascular Health
A study testing OLECOL in people with Overweight and Obesity and Elevated Cholesterol, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effects of daily supplementation of OLECOL for a period of 8 weeks on cardiovascular risk markers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Elevated Cholesterol
- What is being tested?
- OLECOL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2016to Apr 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
- Age between 18 and 70 years
- Total cholesterol levels ≥ 5.0 mmol/L
- BMI 25-35 kg/m2
Who cannot join
- 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, hypertension medication)
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of daily supplementation of OLECOL for a period of 8 weeks on cardiovascular risk markers.
- Conditions
- Overweight and Obesity, Elevated Cholesterol
- Being tested
- OLECOL, Placebo
- Keywords
- Olive leaf extract, Cardiovascular health, Cholesterol
- Medical subject headings
- Overweight, Obesity, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLECOLDietary supplement
Olive leaf extract
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| OLECOL | Active comparator | Olive leaf extract Receives: Dietary Supplement: OLECOL |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipid profile
Measured: 8 weeks
Secondary outcomes (3)
Lipid peroxidation
Measured: 8 weeks
Glucose metabolism
Measured: 8 weeks
Systolic and diastolic blood pressure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yala Stevens, Maastricht University Medical Center
- Investigators
- Ad Masclee, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990637
- Sponsor's protocol ID
- 163004
- Status last verified
- May 2017
- First submitted
- 9 Dec 2016
- Last updated
- 10 May 2017
- Results posted
- No
Publications
Stevens Y, Winkens B, Jonkers D, Masclee A. The effect of olive leaf extract on cardiovascular health markers: a randomized placebo-controlled clinical trial. Eur J Nutr. 2021 Jun;60(4):2111-2120. doi: 10.1007/s00394-020-02397-9. Epub 2020 Oct 9.
PubMed 33034707
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Olive Leaf Extract Administration on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT02990637
- Acronym / sponsor ID
- 163004
- Conditions
- Overweight and Obesity, Elevated Cholesterol
- Keywords
- Olive leaf extract, Cardiovascular health, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 13 Dec 2016 (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.
The purpose of this study is to investigate the effects of daily supplementation of OLECOL for a period of 8 weeks on cardiovascular risk markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLECOL | Active comparator | Dietary Supplement: OLECOLOlive leaf extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy individuals
- Age between 18 and 70 years
- Total cholesterol levels ≥ 5.0 mmol/L
- BMI 25-35 kg/m2
Key exclusion criteria (12 listed)
- 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, hypertension medication)
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
- Use of antibiotics in the 30 days prior to the start of the study
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 |
|---|---|---|
| OLECOLOlive leaf extract | Dietary supplement | OLECOL |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Blood lipid profile
Time frame: 8 weeks
3 secondary outcomes
Lipid peroxidation
Time frame: 8 weeks
Glucose metabolism
Time frame: 8 weeks
Systolic and diastolic blood pressure
Time frame: 8 weeks
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 10 May 2017.
- Derived from this study: PubMed 33034707Stevens Y, Winkens B, Jonkers D, Masclee A. The effect of olive leaf extract on cardiovascular health markers: a randomized placebo-controlled clinical trial. Eur J Nutr. 2021 Jun;60(4):2111-2120. doi: 10.1007/s00394-020-02397-9. Epub 2020 Oct 9.
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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.
Ad Masclee, MD 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 OLECOL in people with Overweight and Obesity and Elevated Cholesterol, 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 4 inclusion and 12 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 10 May 2017. 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?
Blood lipid profile (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02990637, which also lists 1 linked publication.
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 10 May 2017.