Absorption and MetabolismNCT01479699
Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
A study testing Olive leaf extract capsules in people with Absorption and Metabolism and Effect on Vascular Function, run by University of Reading at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on the elasticity of blood vessels and the immune system. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Absorption and Metabolism, Effect on Vascular Function, Effect on Cytokine Concentrations
- What is being tested?
- Olive leaf extract capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Oct 2011
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19-40 years, non-smokers, able to swallow capsules, have a Body Mass Index (BMI) of 18.5-30, have a normal liver function and haematology and a max alcohol intake of <21 units/week
Who cannot join
- Those who suffer from any form of disease, including endocrine disease, liver disease, diabetes mellitus, myocardial infarction, blood clotting disorder, reproductive disorder, gastrointestinal disease or a chronic gastrointestinal disorder.
- Individuals who are vegetarian, have dietary restrictions or on a weight reducing diet will not be recruited.
- Subjects who have been taking antibiotics in previous 3 months before study will not be included in the study
- Females who may be pregnant, or if of childbearing potential and are not using effective contraceptive precautions will be excluded.
- Blood pressure > 150/90 mmHg
- Haemoglobin < 125 g/l for male, < 110 g/l for female
Show all 12Show fewer
- Gamma GT (liver enzymes) > 80 IU/l
- Cholesterol > 6.5 mmol/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
- On any lipid-modifying medication
- On any medication affecting blood clotting
- Individuals taking vitamin and/or fish oil supplements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition, University of Reading
Reading, Berkshire, RG6 5SG
About this study
The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on the elasticity of blood vessels and the immune system.
Read the detailed description
The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on vascular function and cytokine concentrations.
- Being tested
- Olive leaf extract capsules
- Keywords
- Olive leaf extract, Polyphenols, Vascular function, Bioavailability, Cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive leaf extract capsulesDietary supplement
Four capsules taken at baseline each containing 4mg oleuropein
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsule | Placebo comparator | Four placebo capsules containing safflower oil only Receives: Dietary Supplement: Olive leaf extract capsules |
| Olive leaf extract capsule | Active comparator | Four olive leaf capsules. Each containing 4mg oleuropein plus safflower oil. Receives: Dietary Supplement: Olive leaf extract capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption and metabolism
Olive leaf polyphenol metabolites measured in blood and urine samples
Measured: 0. 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post ingestion (blood) 0, 0-4, 4-8 and 8-24 hours post ingestion (urine)
Secondary outcomes (2)
Vascular function
Vascular function was assessed via two methods: Laser Doppler Iontophoresis (LDI) and Digital Volume Pulse (DVP)
Measured: 0, 2, 4, 6 hours post ingestion (LDI) 0, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours post ingestion (DVP)
Cytokine concentration
Concentrations of IL-8, IL-1beta, IL-6, IL-10 and TNF-alpha will be measured in whole blood stimulated with LPS.
Measured: 0, 1, 3 and 6 hours post ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absorption and MetabolismStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Comvita UK
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy PE Spencer, PhD, Principal investigator, University of ReadingIan Rowland, PhD, Principal investigator, University of ReadingParveen Yaqoob, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479699
- Sponsor's protocol ID
- OLE study
- Status last verified
- Nov 2011
- First submitted
- 22 Nov 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
- ClinicalTrials.gov ID
- NCT01479699
- Acronym / sponsor ID
- OLE study
- Keywords
- Olive leaf extract, Polyphenols, Vascular function, Bioavailability, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Comvita UK
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Nov 2011 (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 determine how olive leaf is absorbed and metabolised and also whether it has any effect on the elasticity of blood vessels and the immune system.
Detailed description
The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on vascular function and cytokine concentrations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo capsule | Placebo comparator | Dietary Supplement: Olive leaf extract capsulesFour placebo capsules containing safflower oil only |
| Olive leaf extract capsule | Active comparator | Dietary Supplement: Olive leaf extract capsulesFour olive leaf capsules. Each containing 4mg oleuropein plus safflower oil. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 19-40 years, non-smokers, able to swallow capsules, have a Body Mass Index (BMI) of 18.5-30, have a normal liver function and haematology and a max alcohol intake of <21 units/week
Key exclusion criteria (12 listed)
- Those who suffer from any form of disease, including endocrine disease, liver disease, diabetes mellitus, myocardial infarction, blood clotting disorder, reproductive disorder, gastrointestinal disease or a chronic gastrointestinal disorder.
- Individuals who are vegetarian, have dietary restrictions or on a weight reducing diet will not be recruited.
- Subjects who have been taking antibiotics in previous 3 months before study will not be included in the study
- Females who may be pregnant, or if of childbearing potential and are not using effective contraceptive precautions will be excluded.
- Blood pressure > 150/90 mmHg
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 |
|---|---|---|
| Olive leaf extract capsulesFour capsules taken at baseline each containing 4mg oleuropein | Dietary supplement | Olive leaf extract capsule, Placebo capsule |
Primary outcome
Absorption and metabolism
Time frame: 0. 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post ingestion (blood) 0, 0-4, 4-8 and 8-24 hours post ingestion (urine)
Olive leaf polyphenol metabolites measured in blood and urine samples
2 secondary outcomes
Vascular function
Time frame: 0, 2, 4, 6 hours post ingestion (LDI) 0, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours post ingestion (DVP)
Cytokine concentration
Time frame: 0, 1, 3 and 6 hours post ingestion
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 24 Nov 2011.
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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.
Jeremy PE Spencer, PhD principal investigator
University of Reading
Ian Rowland, PhD principal investigator
University of Reading
Parveen Yaqoob, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive leaf extract capsules in people with Absorption and Metabolism and Effect on Vascular Function, run by University of Reading at 1 site in United Kingdom.
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 1 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 24 Nov 2011. 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 United Kingdom. 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?
Absorption and metabolism (time frame: 0. 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post ingestion (blood) 0, 0-4, 4-8 and 8-24 hours post ingestion (urine)). 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 24 Nov 2011.