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
About this trial
This is an interventional treatment trial for Ulcerative Colitis
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.
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
NCT ID
NCT05486507
First Posted
July 31, 2022
Last Updated
June 1, 2023
Sponsor
University of Central Lancashire
Collaborators
University of Hertfordshire
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
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