Health Benefits of Tart Cherry in Crohn's Disease

NCT ID: NCT06901986

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-06-01

Brief Summary

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.

Conditions

Crohn Disease (CD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Montmorency tart cherry juice

Dietary Supplement: Montmorency tart cherry Description: US grown Montmorency tart cherry 60ml per day for 6 weeks.

Group Type: EXPERIMENTAL

Montmorency tart cherry

Intervention Type: DIETARY_SUPPLEMENT

Montmorency tart cherry 60ml per day for 6 weeks.

Placebo

Taste matched placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Taste matched placebo.

Interventions

Montmorency tart cherry

Montmorency tart cherry 60ml per day for 6 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Taste matched placebo.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hertfordshire

OTHER

Sponsor Role: collaborator

University of Central Lancashire

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Sinclair

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jonathan Sinclair, DSc, PhD

Role: CONTACT

jksinclair@uclan.ac.uk

+447875651533

Other Identifiers

Tart cherry Crohn's disease

Identifier Type: -

Identifier Source: org_study_id