Health Benefits of Tart Cherry in Crohn's Disease

Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults with Mild to Moderate Crohn's Disease.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease (CD)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Montmorency tart cherry

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Sinclair, DSc, PhD; Phone Number: +447875651533; Email: jksinclair@uclan.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Montmorency tart cherry juice; Dietary Supplement: Montmorency tart cherry Description: US grown Montmorency tart cherry 60ml per day for 6 weeks.	Dietary supplement: Montmorency tart cherry; Montmorency tart cherry 60ml per day for 6 weeks.
Placebo Comparator: Placebo; Taste matched placebo.	Dietary supplement: Placebo; Taste matched placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simple clinical colitis activity index	The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.	This parameter will be examined at baseline.
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.	This parameter will be examined at baseline.
International Physical Activity Questionnaire - Short Form	The International Physical Activity Questionnaire - Short Form (IPAQ-SF) addresses the number of days and time spent on physical activity in moderate intensity, vigorous intensity and walking of at least 10-min duration the last 7 days, and also includes time spent sitting on weekdays the last 7 days. The IPAQ-SF sum score is expressed in physical activity Metabolic Equivalent of Task minutes per day or week.	This parameter will be examined at baseline.
IBD Fatigue Scale	The IBD Fatigue Scale is comprised of two components. Part 1 the questionnaire will identify fatigue, its severity, frequency and duration and scores range from 0-20 with a higher score meaning greater fatigue. Part 2 assesses the perceived impact of fatigue on your daily activities and scores range from 0-120 with a higher score meaning greater perceived impact.	This parameter will be examined at baseline
IBD Fatigue Scale	The IBD Fatigue Scale is comprised of two components. Part 1 the questionnaire will identify fatigue, its severity, frequency and duration and scores range from 0-20 with a higher score meaning greater fatigue. Part 2 assesses the perceived impact of fatigue on your daily activities and scores range from 0-120 with a higher score meaning greater perceived impact.	This parameter will be examined at 6 weeks
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.	This parameter will be examined at 6 weeks
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.	This parameter will be examined at 6 weeks
International Physical Activity Questionnaire - Short Form	The International Physical Activity Questionnaire - Short Form (IPAQ-SF) addresses the number of days and time spent on physical activity in moderate intensity, vigorous intensity and walking of at least 10-min duration the last 7 days, and also includes time spent sitting on weekdays the last 7 days. The IPAQ-SF sum score is expressed in physical activity Metabolic Equivalent of Task minutes per day or week.	This parameter will be examined at 6 weeks
Faecal calprotectin	Faecal calprotectin is a stool test that measures the protein calprotectin, released by neutrophils during inflammation, to assess gut inflammation.	This parameter will be examined at baseline
Faecal calprotectin	Faecal calprotectin is a stool test that measures the protein calprotectin, released by neutrophils during inflammation, to assess gut inflammation.	This parameter will be examined at 6 weeks
Gut microbiome	The gut microbiome in individuals with IBD differs significantly from that of healthy individuals, with a reduction in beneficial bacteria and an increase in potentially harmful bacteria.	This parameter will be examined at baseline
Faecal calprotectin	The gut microbiome in individuals with IBD differs significantly from that of healthy individuals, with a reduction in beneficial bacteria and an increase in potentially harmful bacteria.	This parameter will be examined at 6 weeks

Collaborators and Investigators

• Sponsor: University of Central Lancashire
• Collaborators: University of Hertfordshire

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: March 23, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: Tart cherry Crohn's disease

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No