ObesityoliomicroFDGNCT03441802
Gut Microbiota as a Therapeutic Target for CVD
A study testing High quality extra virgin olive oil in people with Obesity, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Background: The Mediterranean Diet (MD) is considered an healthy diet useful in the prevention of cardiovascular disease (CVD). High quality extra virgin olive oil (HQ-EVOO, [1]), an essential component of this diet, exerts a protective effect against CVD. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High quality extra virgin olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2014to 6 Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- normal weight subjects (M and F) with Body Mass Index (BMI) between 18.5 and 24.9 Kg/m2 following MD;
- overweight/obese subjects with a BMI ≥ 25 Kg/m2, not necessarily following MD.
Who cannot join
- eating disorders;
- recent or ongoing antibiotic therapy.
About this study
Official title: Gut Microbiota as a Novel Therapeutic Target for Prevention of Cardiovascular Diseases in Obese and Non-obese Adult Subjects
Background: The Mediterranean Diet (MD) is considered an healthy diet useful in the prevention of cardiovascular disease (CVD). High quality extra virgin olive oil (HQ-EVOO, [1]), an essential component of this diet, exerts a protective effect against CVD. Moreover, the gut microbiota (GM) has recently been recognized as a key factor in driving metabolic activities and involved in the stimulation of host immunity [2]. In particular, Lactic Acid Bacteria (LAB) and their probio-active cellular substances produce beneficial effects in the gastrointestinal tract, thus representing important assets in pathological conditions such as obesity and CVD [3,4].
Objective: The purpose of this study is to demonstrate that 3 months of treatment (MD with 40g/die HQ-EVOO) in 36 subjects (cases: overweight/obese vs controls: normal weight) may change their GM and inflammatory panel.
- Conditions
- Obesity
- Being tested
- High quality extra virgin olive oil
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High quality extra virgin olive oilOther
Cases and controls were given 40 g/die high quality extra virgin olive oil
| Study group | Role | What they receive |
|---|---|---|
| Cases | Active comparator | Not described Receives: Other: High quality extra virgin olive oil |
| Controls | Other | Not described Receives: Other: High quality extra virgin olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-inflammatory cytokines
Measured: Time 0 (T0)
changes in anti-inflammatory cytokines
Measured: after 3 months from T0 (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start8 Jan 2014
- Primary completion6 Jun 2016
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441802
- Sponsor's protocol ID
- olio1_FDG
- Acronym
- oliomicroFDG
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1) Oliveras-López M-J, Berná G, Jurado-Ruiz E, López-García de la Serrana H, Martín F. Consumption of extra-virgin olive oil rich in phenolic compounds has beneficial antioxidant effects in healthy human adults. J Funct Foods 2014;10:475-84
2) Hervert-Hernández D, Goñi I. Dietary Polyphenols and Human Gut Microbiota: a Review. Food Reviews International. 2011;27:154-69.
Woting A, Blaut M. The Intestinal Microbiota in Metabolic Disease. Nutrients. 2016 Apr 6;8(4):202. doi: 10.3390/nu8040202.
PubMed 27058556Boulange CL, Neves AL, Chilloux J, Nicholson JK, Dumas ME. Impact of the gut microbiota on inflammation, obesity, and metabolic disease. Genome Med. 2016 Apr 20;8(1):42. doi: 10.1186/s13073-016-0303-2.
PubMed 27098727Luisi MLE, Lucarini L, Biffi B, Rafanelli E, Pietramellara G, Durante M, Vidali S, Provensi G, Madiai S, Gheri CF, Masini E, Ceccherini MT. Effect of Mediterranean Diet Enriched in High Quality Extra Virgin Olive Oil on Oxidative Stress, Inflammation and Gut Microbiota in Obese and Normal Weight Adult Subjects. Front Pharmacol. 2019 Nov 15;10:1366. doi: 10.3389/fphar.2019.01366. eCollection 2019.
PubMed 31803056
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota as a Novel Therapeutic Target for Prevention of Cardiovascular Diseases in Obese and Non-obese Adult Subjects
- ClinicalTrials.gov ID
- NCT03441802
- Acronym / sponsor ID
- oliomicroFDG / olio1_FDG
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 8 Jan 2014 (actual)
- Primary completion
- 6 Jun 2016 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 22 Feb 2018 (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.
Background: The Mediterranean Diet (MD) is considered an healthy diet useful in the prevention of cardiovascular disease (CVD). High quality extra virgin olive oil (HQ-EVOO, [1]), an essential component of this diet, exerts a protective effect against CVD. Moreover, the gut microbiota (GM) has recently been recognized as a key factor in driving metabolic activities and involved in the stimulation of host immunity [2]. In particular, Lactic Acid Bacteria (LAB) and their probio-active cellular substances produce beneficial effects in the gastrointestinal tract, thus representing important assets in pathological conditions such as obesity and CVD [3,4].
Objective: The purpose of this study is to demonstrate that 3 months of treatment (MD with 40g/die HQ-EVOO) in 36 subjects (cases: overweight/obese vs controls: normal weight) may change their GM and inflammatory panel.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Active comparator | Other: High quality extra virgin olive oil |
| Controls | Other | Other: High quality extra virgin olive oil |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- normal weight subjects (M and F) with Body Mass Index (BMI) between 18.5 and 24.9 Kg/m2 following MD;
- overweight/obese subjects with a BMI ≥ 25 Kg/m2, not necessarily following MD.
Key exclusion criteria (2 listed)
- eating disorders;
- recent or ongoing antibiotic therapy.
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 |
|---|---|---|
| High quality extra virgin olive oilCases and controls were given 40 g/die high quality extra virgin olive oil | Other | Cases, Controls |
Primary outcome
anti-inflammatory cytokines
Time frame: Time 0 (T0)
changes in anti-inflammatory cytokines
Time frame: after 3 months from T0 (T1)
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 22 Feb 2018.
- Background1) Oliveras-López M-J, Berná G, Jurado-Ruiz E, López-García de la Serrana H, Martín F. Consumption of extra-virgin olive oil rich in phenolic compounds has beneficial antioxidant effects in healthy human adults. J Funct Foods 2014;10:475-84
- Background2) Hervert-Hernández D, Goñi I. Dietary Polyphenols and Human Gut Microbiota: a Review. Food Reviews International. 2011;27:154-69.
- Background: PubMed 27058556Woting A, Blaut M. The Intestinal Microbiota in Metabolic Disease. Nutrients. 2016 Apr 6;8(4):202. doi: 10.3390/nu8040202.
- Background: PubMed 27098727Boulange CL, Neves AL, Chilloux J, Nicholson JK, Dumas ME. Impact of the gut microbiota on inflammation, obesity, and metabolic disease. Genome Med. 2016 Apr 20;8(1):42. doi: 10.1186/s13073-016-0303-2.
- Derived from this study: PubMed 31803056Luisi MLE, Lucarini L, Biffi B, Rafanelli E, Pietramellara G, Durante M, Vidali S, Provensi G, Madiai S, Gheri CF, Masini E, Ceccherini MT. Effect of Mediterranean Diet Enriched in High Quality Extra Virgin Olive Oil on Oxidative Stress, Inflammation and Gut Microbiota in Obese and Normal Weight Adult Subjects. Front Pharmacol. 2019 Nov 15;10:1366. doi: 10.3389/fphar.2019.01366. eCollection 2019.
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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 High quality extra virgin olive oil in people with Obesity, run by Fondazione Don Carlo Gnocchi ETS.
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 2 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 22 Feb 2018. 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?
anti-inflammatory cytokines (time frame: Time 0 (T0)). The study lists 2 primary outcomes in all. 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 NCT03441802, which also lists 5 linked publications.
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 22 Feb 2018.