Health Benefits of Tart Cherry in Ulcerative Colitis

• ClinicalTrials.gov Identifier: NCT05486507
• Recruitment Status: Not yet recruiting
• First Posted: August 3, 2022
• Last Update Posted: August 8, 2022
• Sponsor: University of Central Lancashire
• Collaborator: University of Hertfordshire
• Information provided by (Responsible Party): Jonathan Sinclair, University of Central Lancashire

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis	Dietary Supplement: Montmorency tart cherry; Dietary Supplement: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults With Mild to Moderate Ulcerative Colitis; a Placebo Randomized Control Trial
• Estimated Study Start Date: February 1, 2023
• Estimated Primary Completion Date: February 1, 2024
• Estimated Study Completion Date: June 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Inflammatory Bowel Disease Quality of Life Questionnaire [ Time Frame: This parameter will be examined at baseline. ]
   The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).
2. Inflammatory Bowel Disease Quality of Life Questionnaire [ Time Frame: 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 :

1. Simple clinical colitis activity index [ Time Frame: This parameter will be examined at baseline. ]
   The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.
2. Simple clinical colitis activity index [ Time Frame: 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.
3. Hospital anxiety and depression scale [ Time Frame: This parameter will be examined at baseline. ]
   The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression.
4. Hospital anxiety and depression scale [ Time Frame: 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.
5. European Quality of Life Scale [ Time Frame: This parameter will be examined at baseline. ]
   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.
6. European Quality of Life Scale [ Time Frame: 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.
7. International Physical Activity Questionnaire - Short Form [ Time Frame: This parameter will be examined at baseline. ]
   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.
8. International Physical Activity Questionnaire - Short Form [ Time Frame: 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.
9. IBD Fatigue Scale [ Time Frame: This parameter will be examined at baseline ]
   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.
10. IBD Fatigue Scale [ Time Frame: 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.
11. Gut bacteria and fungi Gut bacteria and fungi [ Time Frame: 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.
12. Gut bacteria and fungi [ Time Frame: 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.
13. TNF alpha [ Time Frame: This parameter will be examined at baseline ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
14. TNF alpha [ Time Frame: This parameter will be examined at 6 weeks. ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
15. Interleukin-6 [ Time Frame: This parameter will be examined at baseline ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
16. Interleukin-6 [ Time Frame: This parameter will be examined at 6 weeks. ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
17. Interleukin-17A [ Time Frame: This parameter will be examined at baseline ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
18. Interleukin-17A [ Time Frame: This parameter will be examined at 6 weeks. ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
19. Interleukin-12 [ Time Frame: This parameter will be examined at baseline ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
20. Interleukin-12 [ Time Frame: This parameter will be examined at 6 weeks. ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
21. Interleukin-23 [ Time Frame: This parameter will be examined at baseline ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
22. Interleukin-23 [ Time Frame: This parameter will be examined at 6 weeks. ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
23. Interleukin-10 [ Time Frame: This parameter will be examined at baseline ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
24. Interleukin-10 [ Time Frame: This parameter will be examined at 6 weeks. ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
25. Transforming growth factor Beta [ Time Frame: This parameter will be examined at baseline ]
    This measure will be obtained from blood samples to provide a measure of inflammation.
26. Transforming growth factor Beta [ Time Frame: This parameter will be examined at 6 weeks ]
    This measure will be obtained from blood samples to provide a measure of inflammation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Jonathan Sinclair; +447875651533; jksinclair@uclan.ac.uk

Sponsors and Collaborators

University of Central Lancashire

University of Hertfordshire

More Information

• Responsible Party: Jonathan Sinclair, Professor, University of Central Lancashire
• ClinicalTrials.gov Identifier: NCT05486507
• Other Study ID Numbers: Tart cherry ulcerative colitis
• First Posted: August 3, 2022
• Last Update Posted: August 8, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases