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临床试验/NCT03408847
NCT03408847Unknown不适用

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

Casa Sollievo della Sofferenza IRCCS2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Evaluation of the short-term clinical response

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

Patients will receive a bottle with experiental oil or placebo, consisting of commercial refined olive oil. No diffencences between the two bottles.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

MC-EVOO in addition to steroid therapy

Active Comparator

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.

干预措施: Beclomethasone dipropionate in addition to MC-EVOO (Combination Product)

Refined olive oil and steroid therapy

Placebo Comparator

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.

干预措施: Beclomethasone dipropionate in addition to refined oil (Combination Product)

结局指标

主要结局

Evaluation of the short-term clinical response

时间窗: 12 weeks

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

次要结局

  • Evaluation of the clinical remission(12 weeks)
  • Evaluation of the endoscopic remission(12 weeks)
  • Evaluation of markers of inflammation(12 weeks)
  • Evaluation of adverse events(12 weeks)

研究者

发起方
Casa Sollievo della Sofferenza IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Angelo Andriulli

Medical Doctor

Casa Sollievo della Sofferenza IRCCS

研究点 (2)

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