ObesityOLIWINENCT03101436
Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota
A study testing Extra Virgin Olive Oil and Red Wine in people with Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Trial summary
In this study, the investigators will evaluate the prebiotic effect of a moderate intake of extra virgin olive oil or red wine on the modulation of gut microbiota composition and the improvement of cardiometabolic factors in obese and lean adults subjects. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Extra Virgin Olive Oil and Red Wine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 6 May 2015
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese patients (body mass index (BMI= or > 30kg/m2) with high insulin resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) > 5.5.
- Lean subjects (BMI< 28kg/m2) with low insulin resistance (HOMA-IR< 3.3).
Who cannot join
- Type 2 diabetes
- Acute or chronic infection
- Inflammatory disease or endocrine disorders.
- History of cancer.
- Anti-inflammatory, corticosteroid, hormone, or antibiotic drug treatment
- A history of alcohol abuse or drug dependence
- A restrictive diet or a weight change ≥5 kg during the 3 months prior to the study.
- Intake of prebiotics, probiotics, vitamin supplements or any other medical treatment influencing intestinal microbiota during the 3 months before the start of the study or during the study.
About this study
Official title: Extra Virgin Olive Oil and Red Wine Polyphenols in the Modulation of Fecal Microbiota: an Interventional Study
In this study, the investigators will evaluate the prebiotic effect of a moderate intake of extra virgin olive oil or red wine on the modulation of gut microbiota composition and the improvement of cardiometabolic factors in obese and lean adults subjects.
- Conditions
- Obesity
- Being tested
- Extra Virgin Olive Oil and Red Wine
- Keywords
- Insulin Resistance, Extra Virgin Olive Oil, Red Wine, Diet, Microbiota
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra Virgin Olive Oil and Red WineDietary supplement
Phase I: Extra VIrgin Olive Oil 80 grams per day (1 month)
Washout Period: 15 days
Phase II: Red Wine (270 ml per day) (1 month)
| Study group | Role | What they receive |
|---|---|---|
| Lean Subjects | Experimental | Part 1: Mediterranean diet with added extra virgin olive oil (80 gr per day) (1 month)
Washout 15 days
Part 2: Mediterranean diet with added Red Wine (270 ml per day) (1 month) Receives: Dietary Supplement: Extra Virgin Olive Oil and Red Wine |
| Obese Subjects | Experimental | Part 1: Mediterranean diet with added extra virgin olive oil (80 gr per day) (1 month)
Washout 15 days
Part 2: Mediterranean diet with added Red Wine (270 ml per day) (1 month) Receives: Dietary Supplement: Extra Virgin Olive Oil and Red Wine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota Changes
Changes in microbiome composition
Measured: 1 month
Secondary outcomes (3)
Trimethylamine N-oxide (TMAO) production
Modifications in Trimethylamine N-oxide (TMAO) production
Measured: 1 month
Insulin Resistance
Modifications in Insulin Resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR))
Measured: 1 Month
Lipid Profile
Changes in lipid profile (LDL, HDL, total cholesterol, triglycerides)
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start2 Feb 2015
- Primary completion6 May 2015
- Study completion6 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Phase I: Intervention with Diet (Extra Virgin Olive Oil) Washout Period Phase I: Intervention with Diet (Red Wine)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101436
- Sponsor's protocol ID
- JCMI2017
- Acronym
- OLIWINE
- Status last verified
- Mar 2017
- First submitted
- 29 Mar 2017
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra Virgin Olive Oil and Red Wine Polyphenols in the Modulation of Fecal Microbiota: an Interventional Study
- ClinicalTrials.gov ID
- NCT03101436
- Acronym / sponsor ID
- OLIWINE / JCMI2017
- Conditions
- Obesity
- Keywords
- Insulin Resistance, Extra Virgin Olive Oil, Red Wine, Diet, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 6 May 2015 (actual)
- Study completion
- 6 May 2015 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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.
In this study, the investigators will evaluate the prebiotic effect of a moderate intake of extra virgin olive oil or red wine on the modulation of gut microbiota composition and the improvement of cardiometabolic factors in obese and lean adults subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I: Intervention with Diet (Extra Virgin Olive Oil) Washout Period Phase I: Intervention with Diet (Red Wine)
| Arm | Type | Receives |
|---|---|---|
| Lean Subjects | Experimental | Dietary Supplement: Extra Virgin Olive Oil and Red WinePart 1: Mediterranean diet with added extra virgin olive oil (80 gr per day) (1 month) Washout 15 days Part 2: Mediterranean diet with added Red Wine (270 ml per day) (1 month) |
| Obese Subjects | Experimental | Dietary Supplement: Extra Virgin Olive Oil and Red WinePart 1: Mediterranean diet with added extra virgin olive oil (80 gr per day) (1 month) Washout 15 days Part 2: Mediterranean diet with added Red Wine (270 ml per day) (1 month) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese patients (body mass index (BMI= or > 30kg/m2) with high insulin resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) > 5.5.
- Lean subjects (BMI< 28kg/m2) with low insulin resistance (HOMA-IR< 3.3).
Key exclusion criteria (8 listed)
- Type 2 diabetes
- Acute or chronic infection
- Inflammatory disease or endocrine disorders.
- History of cancer.
- Anti-inflammatory, corticosteroid, hormone, or antibiotic drug treatment
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 |
|---|---|---|
| Extra Virgin Olive Oil and Red WinePhase I: Extra VIrgin Olive Oil 80 grams per day (1 month) Washout Period: 15 days Phase II: Red Wine (270 ml per day) (1 month) | Dietary supplement | Lean Subjects, Obese Subjects |
Primary outcome
Microbiota Changes
Time frame: 1 month
Changes in microbiome composition
3 secondary outcomes
Trimethylamine N-oxide (TMAO) production
Time frame: 1 month
Insulin Resistance
Time frame: 1 Month
Lipid Profile
Time frame: 1 Month
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 5 Apr 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Extra Virgin Olive Oil and Red Wine in people with Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
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 2 inclusion and 8 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Microbiota Changes (time frame: 1 month). 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 5 Apr 2017.