About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Diabetes
HIV
Hepatitis B and C infection
Abscesses
Trial design
Parallel
Treatments tested in this trial
Montmorency tart cherry
Dietary supplementMontmorency tart cherry 60ml per day for 6 weeks.
Placebo
Dietary supplementTaste matched placebo.
Treatment groups
Trial outcomes
Primary outcomes
Inflammatory Bowel Disease Quality of Life Questionnaire
The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).
Inflammatory Bowel Disease Quality of Life Questionnaire
The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).
Secondary outcomes
Simple clinical colitis activity index
The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.
Hospital anxiety and depression scale
The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression.
European Quality of Life Scale
The European Quality of Life Scale is an instrument for measuring quality of life across patient groups and cultures and is conceptually distinct from health status or other causal indicators of quality of life. A higher score indicates higher quality of life.
European Quality of Life Scale
The European Quality of Life Scale is an instrument for measuring quality of life across patient groups and cultures and is conceptually distinct from health status or other causal indicators of quality of life. A higher score indicates higher quality of life.
Locations
Sponsors and contacts
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University of Central Lancashire
Lead sponsor
University of Hertfordshire
Collaborator
This trial is not recruiting at the moment. You can still explore other options: