Health Benefits of Tart Cherry in Crohn's Disease

NCT06901986 | Not Yet Recruiting

• 1 other identifier: Tart cherry Crohn's disease
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (2)

• 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).

  This parameter will be examined at baseline.

• 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).

  This parameter will be examined at 6 weeks

Secondary Outcomes (12)

• 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 baseline.

• 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 baseline.

Study Arms (2)

Montmorency tart cherry juice

EXPERIMENTAL

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

Dietary Supplement: Montmorency tart cherry

Placebo

PLACEBO COMPARATOR

Taste matched placebo.

Dietary Supplement: Placebo

Interventions

Montmorency tart cherry DIETARY_SUPPLEMENT

Montmorency tart cherry 60ml per day for 6 weeks.

Montmorency tart cherry juice

Placebo DIETARY_SUPPLEMENT

Taste matched placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Lancashire: lead
• University of Hertfordshire: collaborator

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Jonathan Sinclair, DSc, PhD

CONTACT

+447875651533; jksinclair@uclan.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share