Health Benefits of Tart Cherry in Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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The Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults With Mild to Moderate Ulcerative Colitis; a Placebo Randomized Control Trial

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Dietary Supplement: Montmorency tart cherry
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montmorency tart cherry juice<br> | Dietary Supplement: Montmorency tart cherry<br>* US grown Montmorency tart cherry 60ml per day for 6 weeks.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Taste matched placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | This parameter will be examined at baseline. | 
| 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). | This parameter will be examined at 6 weeks. | 

Secondary Outcome Measures

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