跳至主要内容
临床试验/NCT05486507
NCT05486507已完成不适用

The Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults With Mild to Moderate Ulcerative Colitis; a Placebo Randomized Control Trial

University of Central Lancashire3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
3
主要终点
Inflammatory Bowel Disease Quality of Life Questionnaire

研究概览

简要总结

Ulcerative Colitis (UC) is a long-term inflammatory condition of the digestive tract. People with UC often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. In addition, they require long-term treatment with frequent negative effects, the need of surgery and hospitalisations. Therefore, people with UC report a lower health-related quality of life (HRQOL) compared with healthy individuals. The most common medication for inflammatory bowel disease is a strong immunosuppressant which has previously (in 2017) been found to be the most expensive medication prescribed at hospitals in the NHS. Unfortunately, biologics has a lot of negative side effects and thus reducing the need of them in patients can benefit both the NHS as a whole by reducing the cost and improving the quality of life of patients by reducing the unwanted side effects of the biologics. Supplementation of Montmorency tart cherry juice might be a simple, safe, and low-cost intervention for improving symptoms in patients with UC. This is because it has the potential to naturally reduce inflammation in the digestive system and thus improve symptoms. Research in animal models has shown a potential for improvement in physiological responses with similar supplements including blueberries, black raspberries and even Montmorency tart cherries, with only one study in human participants exploring bilberry supplementation.

However, despite anthocyanins concentrations from Montmorency tart cherries being superior to other berries, dietary interventions using tart cherry supplementation for UC have not received any attention in human participants. The primary purpose of the proposed investigation is to undertake a placebo randomized control trial examining the ability of a Montmorency tart cherry juice supplement to provide symptom relief and health related wellbeing outcomes in those with mild to moderately active UC and to understand the biological mechanisms behind any changes in symptoms.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • An established diagnosis of UC for at least 6 months
  • Current mild to moderate disease activity
  • Age between 18 and 65 years
  • Stable use of medication for at least 3 months respectively.

排除标准

  • Hepatitis B and C infection
  • Abscesses
  • Unstable medical conditions that would likely prevent the subject from completing the study
  • Food allergies to cherries.

结局指标

主要结局

Inflammatory Bowel Disease Quality of Life Questionnaire

时间窗: This parameter will be examined at 6 weeks.

The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).

次要结局

  • Simple clinical colitis activity index(This parameter will be examined at 6 weeks.)
  • Interleukin-23(This parameter will be examined at 6 weeks.)
  • European Quality of Life Scale(This parameter will be examined at 6 weeks.)
  • Hospital anxiety and depression scale(This parameter will be examined at 6 weeks.)
  • Gut bacteria and fungi(This parameter will be examined at 6 weeks.)
  • Interleukin-6(This parameter will be examined at 6 weeks.)
  • Interleukin-10(This parameter will be examined at 6 weeks.)
  • Transforming growth factor Beta(This parameter will be examined at 6 weeks)
  • International Physical Activity Questionnaire - Short Form(This parameter will be examined at 6 weeks.)
  • IBD Fatigue Scale(This parameter will be examined at 6 weeks)
  • Gut bacteria and fungi Gut bacteria and fungi(This parameter will be examined at baseline)
  • TNF alpha(This parameter will be examined at 6 weeks.)
  • Interleukin-17A(This parameter will be examined at 6 weeks.)
  • Interleukin-12(This parameter will be examined at 6 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Sinclair

Professor

University of Central Lancashire

研究点 (3)

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