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Ulcerative Colitis Chronic MildEVORCUNCT03408847

Monocultivar Coratina Extra Virgin Olive Oil in UC Patients

A study testing Beclomethasone dipropionate in addition to MC-EVOO and Beclomethasone dipropionate in addition to refined oil in people with Ulcerative Colitis Chronic Mild, run by Casa Sollievo della Sofferenza IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Epidemiological studies suggest that daily intake of fruits and vegetables high in polyphenols or the addition of olive oil containing many polyphenols is associated with a reduced risk of chronic diseases including cardiovascular, metabolic, neurodegenerative, and inflammatory bowel conditions. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Ulcerative Colitis Chronic Mild
What is being tested?
Beclomethasone dipropionate in addition to MC-EVOO and Beclomethasone dipropionate in addition to refined oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteItaly
Study dates
20 Nov 2017to 31 Dec 2019
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with active UC (diagnosed for at least 3 months) aged 18 to 70 years
  • Patients with mild to moderate disease (calculated by Mayo score).
  • Patients can provide their informed consent to participate in the study

Who cannot join

  • Patients with Crohn's disease
  • Patients with complicated disease, who are candidates for urgent surgery
  • Patients with colostomy
  • Patients with contraindications to steroid therapy (diabetes mellitus, severe osteoporosis, vertebral fractures, previous intolerance to steroid therapy)
  • Patients with unstable or inappropriately controlled cardiovascular, pulmonary, hepatic, renal or hematologic diseases
  • Patients who are not compliant
  • Patients abusing alcohol or drugs

Trial locations and contacts

1 site in 1 country.

Fabrizio Bossa, MD contact

+39 0882416281

f.bossa@operapadrepio.it

Italy1 site, 1 recruiting
  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

    Angelo Andriulli, MD, 0039 0882 410263, a.andriulli@operapadrepio.it

    Orazio Palmieri, BSc, 0039 0882416281, o.palmieri@operapadrepio.it

    Recruiting

Other trials in Italy

About this study

Official title: Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis

Epidemiological studies suggest that daily intake of fruits and vegetables high in polyphenols or the addition of olive oil containing many polyphenols is associated with a reduced risk of chronic diseases including cardiovascular, metabolic, neurodegenerative, and inflammatory bowel conditions.

In vivo experiments demonstrated that the administration of a diet associated with daily intake of extra virgin olive oil (EVOO) reduces histological lesions and symptomatology in rats with a dextran sulfate sodium (DDS) induced colitis. A diet supplemented with hydroxytyrosol (a component of olive oil) showed a reduction of the inflammatory process at the inflamed colon of the rats.

Read the detailed description

Ulcerative colitis (UC) is a chronic inflammatory bowel disease of unknown etiology, which usually occurs in young adults (II-IV decade of life).

Epidemiological data have shown a north-south gradient of both incidence and prevalence of UC in European countries, with a higher prevalence in northern European countries than in the Mediterranean area. However, recent data show a reduction in these differences in the last two decades. The reasons of this reduction are unknown, but it is possible that these differences are related to a change in dietary habits in southern European countries where a diet rich in fresh fruits and vegetables (the so-called "Mediterranean diet") is gradually being replaced by a typical diet of the industrialized countries of northern Europe, characterized by high consumption of frozen or pre-packaged foods of the food industry.

These changes in the diet regime have also replaced the type of oil contained in foods, ranging from olive oil (typical of the Mediterranean diet) to fats of animal origin or vegetable oils not coming from the olives.

Olive oil is universally recognized as the symbol of the Mediterranean diet and its beneficial properties have been extensively studied.

In particular, there are scientific evidence showing an effect of virgin olive oil on the lipid metabolism, on chronic inflammation, on blood pressure, and the regulation and detoxification of free radicals.

In particular, beneficial effects would in part be related to polyphenols, potent natural antioxidants contained in olive oil.

Monocultivar Coratina extra virgin olive oil (MC-EVOO) is an Apulian olive oil that, while possessing an extraordinary health effect superior to other cultivars, is not very used because of its distinctive characteristics of bitter and spicy. The bitter and the spicy of the extra virgin olive oil obtained from Coratina monocultivar are not defects in the oil but are the expression of a very high concentration of polyphenols (up to 800-1000 mg / kg of oil) compared to other varieties which, as well as providing extraordinary health benefits to the consumer, extend the expiration date of the oil itself, preserving it from oxidative action.

The MC-EVOO is a typical of the Apulia Region and it is characterized by:

  1. high content of polyphenols
  2. natural 100% product, with no residues of chemical solvents and other toxic and harmful contaminants.

No studies have been published so far that have demonstrated a potential toxic effects of polyphenols. Instead, EVOO-C supplementation could potentially have positive effects on lipid metabolism and body weight.

Epidemiological studies suggest that daily intake of fruits and vegetables high in polyphenols or the addition of olive oil containing many polyphenols is associated with a reduced risk of chronic diseases including cardiovascular, inflammatory, metabolic, neurodegenerative, and some neoplasms.

Also the results of in vitro study showed these properties but these results have to be carefully evaluated because in vivo the polyphenols, after being absorbed into the intestine and conjugated in the liver, arrive in the blood in methylated, sulphated and glycogenated form.

These molecules are completely different from the structural point of view of native molecules. Moreover, their presence is in the concentration of nano or micro molecules. These molecules have different biological properties from native ones and are distributed differently in different tissues and cells.

In addition, in the in-vitro studies native polyphenol molecules have been used at high concentrations, or above physiological (over 100 micromoles).

This is the first reason why a clinical trial case study was planned. Polyphenols also modulate cell membranes, enzymes, transcription factors and receptors. This is the second reason why nutrigenomics will be studied during the course of the clinical trial to evaluate the effects of polyphenols on the molecular and cellular mechanisms of the inflammatory processes that are present in the ulcerative colitis.

In vivo experiments demonstrated that the administration of a diet associated with daily intake of EVOO reduces histological lesions and symptomatology in rats with a DDS induced colitis. A diet supplemented with hydroxytyrosol (a component of olive oil) showed a reduction of the inflammatory process at the inflamed colon of the rats.

These data show that EVOO supplementation in a diet can improve the course of the disease.

Experimental studies in humans are limited. The first study published over 25 years ago concluded that administering a supplement of fish oil to the diet produced a modest reduction in corticosteroid in the active phases of the disease, but not a benefit in maintenance therapy over olive oil. This work presents important limitations:

  1. the content of polyphenols in the oils used is unknown
  2. the remission time between the two oils was not statistically significant
  3. there are no data on inflammation of the colon before and after treatment Recently, an in vitro study performed on intestinal mucosa obtained from 14 active UC patients showed that samples treated with oleuropein had a reduced expression of two inflammatory factors, COX-2 and IL-17, suggesting that olive oil containing oleuropein can improve inflammatory status.

The aim of the study is to evaluate whether MC- EVOO supplementation in moderate to severe UC patients needing a steroid cycle may increase the clinical response rate to medical therapy.

Being tested
Beclomethasone dipropionate in addition to MC-EVOO, Beclomethasone dipropionate in addition to refined oil
Keywords
Ulcerative colitis, UC, Extra virgin olive oil, Polyphenols
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beclomethasone dipropionate in addition to MC-EVOOCombination product

    Oral beclomethasone dipropionate at dose of 10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks plus MC- EVOO for 12 weeks at a dose of 2 tablespoons per day (1 before lunch and 1 before dinner). Each spoon will contain 10 grams of oil containing 5 mg of biophenols.

  • Beclomethasone dipropionate in addition to refined oilCombination product

    Oral beclomethasone dipropionate (10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks) plus placebo consisting of refined olive oil with low biophenols.

Study groups in NCT03408847
Study groupRoleWhat they receive
MC-EVOO in addition to steroid therapyActive comparatorOral beclomethasone dipropionate at dose of 10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks plus MC- EVOO for 12 weeks at a dose of 2 tablespoons per day (1 before lunch and 1 before dinner). Each spoon will contain 10 grams of oil containing 5 mg of biophenols.
Receives: Combination Product: Beclomethasone dipropionate in addition to MC-EVOO
Refined olive oil and steroid therapyPlacebo comparatorOral beclomethasone dipropionate (10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks) plus placebo consisting of refined olive oil with low biophenols.
Receives: Combination Product: Beclomethasone dipropionate in addition to refined oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the short-term clinical response

    Evaluation of the short-term clinical response rate in the 2 treatment groups

    Measured: 12 weeks

Secondary outcomes (4)
  1. Evaluation of the clinical remission

    Evaluation of the clinical remission rate in the short term in the 2 treatment groups

    Measured: 12 weeks

  2. Evaluation of the endoscopic remission

    Evaluation of the endoscopic remission rate after 3 months in the 2 treatment groups

    Measured: 12 weeks

  3. Evaluation of markers of inflammation

    Evaluation of the rate of patients with normalization of markers of inflammation in the short and medium term in the 2 treatment groups

    Measured: 12 weeks

  4. Evaluation of adverse events

    Evaluation of the rate of adverse events in the 2 treatment groups

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2018
  2. Study start20 Nov 2017
  3. Primary completion1 Dec 2018 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03408847
Sponsor's protocol ID
EVO-RCU-2017
Acronym
EVORCU
Status last verified
Feb 2018
First submitted
24 Nov 2017
Last updated
7 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011 Nov 3;365(18):1713-25. doi: 10.1056/NEJMra1102942. No abstract available.

    PubMed 22047562
  • Ng SC, Bernstein CN, Vatn MH, Lakatos PL, Loftus EV Jr, Tysk C, O'Morain C, Moum B, Colombel JF; Epidemiology and Natural History Task Force of the International Organization of Inflammatory Bowel Disease (IOIBD). Geographical variability and environmental risk factors in inflammatory bowel disease. Gut. 2013 Apr;62(4):630-49. doi: 10.1136/gutjnl-2012-303661. Epub 2013 Jan 18.

    PubMed 23335431
  • Koloski NA, Bret L, Radford-Smith G. Hygiene hypothesis in inflammatory bowel disease: a critical review of the literature. World J Gastroenterol. 2008 Jan 14;14(2):165-73. doi: 10.3748/wjg.14.165.

    PubMed 18186549
  • Sanchez-Fidalgo S, Sanchez de Ibarguen L, Cardeno A, Alarcon de la Lastra C. Influence of extra virgin olive oil diet enriched with hydroxytyrosol in a chronic DSS colitis model. Eur J Nutr. 2012 Jun;51(4):497-506. doi: 10.1007/s00394-011-0235-y. Epub 2011 Aug 27.

    PubMed 21874330
  • Takashima T, Sakata Y, Iwakiri R, Shiraishi R, Oda Y, Inoue N, Nakayama A, Toda S, Fujimoto K. Feeding with olive oil attenuates inflammation in dextran sulfate sodium-induced colitis in rat. J Nutr Biochem. 2014 Feb;25(2):186-92. doi: 10.1016/j.jnutbio.2013.10.005. Epub 2013 Nov 8.

    PubMed 24445043
  • Reddy KVK, Naidu KA. Oleic acid, hydroxytyrosol and n-3 fatty acids collectively modulate colitis through reduction of oxidative stress and IL-8 synthesis; in vitro and in vivo studies. Int Immunopharmacol. 2016 Jun;35:29-42. doi: 10.1016/j.intimp.2016.03.019. Epub 2016 Mar 24.

    PubMed 27016717
  • Hawthorne AB, Daneshmend TK, Hawkey CJ, Belluzzi A, Everitt SJ, Holmes GK, Malkinson C, Shaheen MZ, Willars JE. Treatment of ulcerative colitis with fish oil supplementation: a prospective 12 month randomised controlled trial. Gut. 1992 Jul;33(7):922-8. doi: 10.1136/gut.33.7.922.

    PubMed 1353742
  • Larussa T, Oliverio M, Suraci E, Greco M, Placida R, Gervasi S, Marasco R, Imeneo M, Paolino D, Tucci L, Gulletta E, Fresta M, Procopio A, Luzza F. Oleuropein Decreases Cyclooxygenase-2 and Interleukin-17 Expression and Attenuates Inflammatory Damage in Colonic Samples from Ulcerative Colitis Patients. Nutrients. 2017 Apr 15;9(4):391. doi: 10.3390/nu9040391.

    PubMed 28420140

Questions about this trial

What is this clinical trial studying?

A study testing Beclomethasone dipropionate in addition to MC-EVOO and Beclomethasone dipropionate in addition to refined oil in people with Ulcerative Colitis Chronic Mild, run by Casa Sollievo della Sofferenza IRCCS at 1 site in Italy.

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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Feb 2018. 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 Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fabrizio Bossa, MD (+39 0882416281, f.bossa@operapadrepio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the short-term clinical response (time frame: 12 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 NCT03408847, which also lists 8 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 7 Feb 2018.

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