Health Benefits of Tart Cherry in Ulcerative Colitis

Not Applicable

Active, not recruiting

• Conditions: Ulcerative Colitis
• Interventions: Dietary Supplement: Montmorency tart cherry; Dietary Supplement: Placebo

• Registration Number: NCT05486507
• Lead Sponsor: University of Central Lancashire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-03
• Study Start: 2023-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Montmorency tart cherry juice	Montmorency tart cherry	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Inflammatory Bowel Disease Quality of Life Questionnaire	This parameter will be examined at 6 weeks.	The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).

Secondary Outcome Measures

Name	Time	Method
Simple clinical colitis activity index	This parameter will be examined at 6 weeks.	The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.
Interleukin-23	This parameter will be examined at 6 weeks.	This measure will be obtained from blood samples to provide a measure of inflammation.
European Quality of Life Scale	This parameter will be examined at 6 weeks.	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.
Hospital anxiety and depression scale	This parameter will be examined at 6 weeks.	The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression.
Gut bacteria and fungi	This parameter will be examined at 6 weeks.	Gut bacteria and fungi will be measured from feacal samples with higher values indicating greater levels of bacteria and fungi in the gut.
Interleukin-6	This parameter will be examined at 6 weeks.	This measure will be obtained from blood samples to provide a measure of inflammation.
Interleukin-10	This parameter will be examined at 6 weeks.	This measure will be obtained from blood samples to provide a measure of inflammation.
Transforming growth factor Beta	This parameter will be examined at 6 weeks	This measure will be obtained from blood samples to provide a measure of inflammation.
International Physical Activity Questionnaire - Short Form	This parameter will be examined at 6 weeks.	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.
IBD Fatigue Scale	This parameter will be examined at 6 weeks	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.
Gut bacteria and fungi Gut bacteria and fungi	This parameter will be examined at baseline	Gut bacteria and fungi will be measured from feacal samples with higher values indicating greater levels of bacteria and fungi in the gut.
TNF alpha	This parameter will be examined at 6 weeks.	This measure will be obtained from blood samples to provide a measure of inflammation.
Interleukin-17A	This parameter will be examined at 6 weeks.	This measure will be obtained from blood samples to provide a measure of inflammation.
Interleukin-12	This parameter will be examined at 6 weeks.	This measure will be obtained from blood samples to provide a measure of inflammation.

Trial Locations

Locations (2)

University of Hertfordshire; 🇬🇧 London, United Kingdom

University of Central Lancashire; 🇬🇧 Preston, Lancashire, United Kingdom