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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Dietary supplement: Montmorency tart cherry; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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
Placebo Comparator: Placebo	Dietary supplement: Placebo; Taste matched placebo.
Experimental: Montmorency tart cherry juice	Dietary supplement: Montmorency tart cherry; US grown Montmorency tart cherry 60ml per day for 6 weeks.

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.
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 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 baseline.
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 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 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 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 6 weeks.
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
Gut bacteria and fungi Gut bacteria and fungi	Gut bacteria and fungi will be measured from feacal samples with higher values indicating greater levels of bacteria and fungi in the gut.	This parameter will be examined at baseline
Gut bacteria and fungi	Gut bacteria and fungi will be measured from feacal samples with higher values indicating greater levels of bacteria and fungi in the gut.	This parameter will be examined at 6 weeks.
TNF alpha	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
TNF alpha	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Interleukin-6	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Interleukin-6	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Interleukin-17A	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Interleukin-17A	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Interleukin-12	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Interleukin-12	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Interleukin-23	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Interleukin-23	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Interleukin-10	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Interleukin-10	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Transforming growth factor Beta	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Transforming growth factor Beta	This measure will be obtained from blood samples to provide a measure of inflammation.	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): July 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 31, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Tart cherry ulcerative colitis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No