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Health Benefits of Tart Cherry in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05486507
Recruitment Status : Not yet recruiting
First Posted : August 3, 2022
Last Update Posted : August 8, 2022
Sponsor:
Collaborator:
University of Hertfordshire
Information provided by (Responsible Party):
Jonathan Sinclair, 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.


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

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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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05486507


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

Sponsors and Collaborators
University of Central Lancashire
University of Hertfordshire
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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    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases