Health Benefits of Tart Cherry in Ulcerative Colitis

NCT05486507 | Completed

• 1 other identifier: Tart cherry ulcerative colitis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ulcerative Colitis

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 (26)

• Simple clinical colitis activity index

  This parameter will be examined at baseline.

• Simple clinical colitis activity index

  This parameter will be examined at 6 weeks.

• Hospital anxiety and depression scale

  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.

Study Arms (2)

Montmorency tart cherry juice

EXPERIMENTAL

Dietary Supplement: Montmorency tart cherry

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Montmorency tart cherry DIETARY_SUPPLEMENT

US grown 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 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.

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

Study Sites (2)

University of Central Lancashire

Preston, Lancashire, PR1 2HE, United Kingdom

Location

University of Hertfordshire

London, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

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: July 31, 2022
• First Posted: August 3, 2022
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

GB (2)