Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults with Mild to Moderate Crohn's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Inflammatory Bowel Disease Quality of Life Questionnaire
研究概览
简要总结
Crohn's disease (CD) is a long-term inflammatory condition of the digestive tract. People with CD often experience unpredictable and debilitating symptoms, including abdominal pain, diarrhea, and fatigue. Additionally, they require long-term treatment, which is often associated with frequent negative effects, the need for surgery, and hospitalizations. As a result, individuals with CD report a lower health-related quality of life (HRQOL) compared to healthy individuals.
The most common medication for inflammatory bowel disease is a strong immunosuppressant, which was identified in 2017 as the most expensive medication prescribed in NHS hospitals. Unfortunately, biologics have significant side effects, and reducing the reliance on them could benefit both the NHS by lowering costs and patients by minimizing unwanted side effects.
Supplementation with Montmorency tart cherry juice may offer a simple, safe, and cost-effective intervention for improving symptoms in individuals with CD. This is due to its potential to naturally reduce inflammation in the digestive system, thereby alleviating symptoms. Research in animal models has shown potential improvements in physiological responses with similar supplements, including blueberries, black raspberries, and Montmorency tart cherries, though only one study in human participants has explored bilberry supplementation.
Despite Montmorency tart cherries having superior anthocyanin concentrations compared to other berries, dietary interventions using tart cherry supplementation for CD have not been explored in human participants. The primary aim of the proposed investigation is to conduct a placebo-controlled randomized trial to examine whether Montmorency tart cherry juice supplementation can provide symptom relief and improve health-related well-being in individuals with mild to moderately active CD, as well as to understand the biological mechanisms underlying any observed symptom changes.
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
- 否
入选标准
- •An established diagnosis of CDfor 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 baseline.)
- Hospital anxiety and depression scale(This parameter will be examined at 6 weeks)
- European Quality of Life Scale(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 microbiome(This parameter will be examined at baseline)
- Faecal calprotectin(This parameter will be examined at 6 weeks)
研究者
Jonathan Sinclair
Professor
University of Central Lancashire