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Health Benefits of Tart Cherry in Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Montmorency tart cherry
Placebo
Sponsored by
University of Central Lancashire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Montmorency tart cherry juice

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    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).
    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).

    Secondary Outcome Measures

    Simple clinical colitis activity index
    The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.
    Simple clinical colitis activity index
    The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    TNF alpha
    This measure will be obtained from blood samples to provide a measure of inflammation.
    TNF alpha
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-6
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-6
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-17A
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-17A
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-12
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-12
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-23
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-23
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-10
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Interleukin-10
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Transforming growth factor Beta
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Transforming growth factor Beta
    This measure will be obtained from blood samples to provide a measure of inflammation.

    Full Information

    First Posted
    July 31, 2022
    Last Updated
    June 1, 2023
    Sponsor
    University of Central Lancashire
    Collaborators
    University of Hertfordshire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05486507
    Brief Title
    Health Benefits of Tart Cherry in Ulcerative Colitis
    Official Title
    The Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults With Mild to Moderate Ulcerative Colitis; a Placebo Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Central Lancashire
    Collaborators
    University of Hertfordshire

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Montmorency tart cherry juice
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Montmorency tart cherry
    Intervention Description
    US grown Montmorency tart cherry 60ml per day for 6 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Taste matched placebo.
    Primary Outcome Measure Information:
    Title
    Inflammatory Bowel Disease Quality of Life Questionnaire
    Description
    The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).
    Time Frame
    This parameter will be examined at baseline.
    Title
    Inflammatory Bowel Disease Quality of Life Questionnaire
    Description
    The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).
    Time Frame
    This parameter will be examined at 6 weeks.
    Secondary Outcome Measure Information:
    Title
    Simple clinical colitis activity index
    Description
    The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.
    Time Frame
    This parameter will be examined at baseline.
    Title
    Simple clinical colitis activity index
    Description
    The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    Hospital anxiety and depression scale
    Description
    The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression.
    Time Frame
    This parameter will be examined at baseline.
    Title
    Hospital anxiety and depression scale
    Description
    The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    European Quality of Life Scale
    Description
    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.
    Time Frame
    This parameter will be examined at baseline.
    Title
    European Quality of Life Scale
    Description
    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.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    International Physical Activity Questionnaire - Short Form
    Description
    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.
    Time Frame
    This parameter will be examined at baseline.
    Title
    International Physical Activity Questionnaire - Short Form
    Description
    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.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    IBD Fatigue Scale
    Description
    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.
    Time Frame
    This parameter will be examined at baseline
    Title
    IBD Fatigue Scale
    Description
    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.
    Time Frame
    This parameter will be examined at 6 weeks
    Title
    Gut bacteria and fungi Gut bacteria and fungi
    Description
    Gut bacteria and fungi will be measured from feacal samples with higher values indicating greater levels of bacteria and fungi in the gut.
    Time Frame
    This parameter will be examined at baseline
    Title
    Gut bacteria and fungi
    Description
    Gut bacteria and fungi will be measured from feacal samples with higher values indicating greater levels of bacteria and fungi in the gut.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    TNF alpha
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at baseline
    Title
    TNF alpha
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    Interleukin-6
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at baseline
    Title
    Interleukin-6
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    Interleukin-17A
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at baseline
    Title
    Interleukin-17A
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    Interleukin-12
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at baseline
    Title
    Interleukin-12
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    Interleukin-23
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at baseline
    Title
    Interleukin-23
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    Interleukin-10
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at baseline
    Title
    Interleukin-10
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at 6 weeks.
    Title
    Transforming growth factor Beta
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at baseline
    Title
    Transforming growth factor Beta
    Description
    This measure will be obtained from blood samples to provide a measure of inflammation.
    Time Frame
    This parameter will be examined at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan Sinclair
    Phone
    +447875651533
    Email
    jksinclair@uclan.ac.uk

    12. IPD Sharing Statement

    Learn more about this trial

    Health Benefits of Tart Cherry in Ulcerative Colitis

    We'll reach out to this number within 24 hrs