Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 15 for:    hydroxytyrosol

Monocultivar Coratina Extra Virgin Olive Oil in UC Patients (EVORCU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03408847
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Fondazione Schena
Information provided by (Responsible Party):
Angelo Andriulli, Casa Sollievo della Sofferenza IRCCS

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Chronic Mild Combination Product: Beclomethasone dipropionate in addition to MC-EVOO Combination Product: Beclomethasone dipropionate in addition to refined oil Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot study
Masking: Double (Participant, Investigator)
Masking Description: Patients will receive a bottle with experiental oil or placebo, consisting of commercial refined olive oil. No diffencences between the two bottles.
Primary Purpose: Supportive Care
Official Title: Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Active Comparator: MC-EVOO in addition to steroid therapy
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.
Combination Product: Beclomethasone dipropionate in addition to MC-EVOO
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.

Placebo Comparator: Refined olive oil and steroid therapy
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.
Combination Product: Beclomethasone dipropionate in addition to refined oil
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.




Primary Outcome Measures :
  1. Evaluation of the short-term clinical response [ Time Frame: 12 weeks ]
    Evaluation of the short-term clinical response rate in the 2 treatment groups


Secondary Outcome Measures :
  1. Evaluation of the clinical remission [ Time Frame: 12 weeks ]
    Evaluation of the clinical remission rate in the short term in the 2 treatment groups

  2. Evaluation of the endoscopic remission [ Time Frame: 12 weeks ]
    Evaluation of the endoscopic remission rate after 3 months in the 2 treatment groups

  3. Evaluation of markers of inflammation [ Time Frame: 12 weeks ]
    Evaluation of the rate of patients with normalization of markers of inflammation in the short and medium term in the 2 treatment groups

  4. Evaluation of adverse events [ Time Frame: 12 weeks ]
    Evaluation of the rate of adverse events in the 2 treatment groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408847


Contacts
Layout table for location contacts
Contact: Fabrizio Bossa, MD +39 0882416281 f.bossa@operapadrepio.it

Locations
Layout table for location information
Italy
IRCCS Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Contact: Angelo Andriulli, MD    0039 0882 410263    a.andriulli@operapadrepio.it   
Contact: Orazio Palmieri, BSc    0039 0882416281    o.palmieri@operapadrepio.it   
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Fondazione Schena

Publications:

Layout table for additonal information
Responsible Party: Angelo Andriulli, Medical Doctor, Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier: NCT03408847     History of Changes
Other Study ID Numbers: EVO-RCU-2017
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Angelo Andriulli, Casa Sollievo della Sofferenza IRCCS:
Ulcerative colitis
UC
Extra virgin olive oil
Polyphenols

Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents