NCT05486507Completed
Health Benefits of Tart Cherry in Ulcerative Colitis
The Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults With Mild to Moderate Ulcerative Colitis; a Placebo Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 24 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 31 Jul 2022
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- University of Central Lancashire
- Diseases
- Ulcerative colitis
- NCT number
- NCT05486507
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Sept 2023 to the primary completion date, 1 Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes
- HIV
- Hepatitis B and C infection
- Unstable medical conditions that would likely prevent the subject from completing the study
- Food allergies to cherries.
Other
- Abscesses
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Hertfordshire Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University of Central Lancashire Coordinator of this site? Confirm its status | Preston | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.