Health Benefits of Tart Cherry in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05486507
• Other study ID #: Tart cherry ulcerative colitis
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2023
• Source: University of Central Lancashire
• Contact: Jonathan Sinclair
• Phone: +447875651533
• Email: jksinclair[@]uclan.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Dietary Supplement:
• Montmorency tart cherry
US grown Montmorency tart cherry 60ml per day for 6 weeks.
• Placebo
Taste matched placebo.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Lancashire	University of Hertfordshire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	TNF alpha	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Secondary	TNF alpha	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Secondary	Interleukin-6	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Secondary	Interleukin-6	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Secondary	Interleukin-17A	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Secondary	Interleukin-17A	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Secondary	Interleukin-12	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Secondary	Interleukin-12	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Secondary	Interleukin-23	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Secondary	Interleukin-23	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Secondary	Interleukin-10	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at baseline
Secondary	Interleukin-10	This measure will be obtained from blood samples to provide a measure of inflammation.	This parameter will be examined at 6 weeks.
Secondary	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
Secondary	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