Clinical trial NCT05486507: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
Collaborators: name: University of Hertfordshire
First posted: 2022-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Inflammatory Bowel Disease Quality of Life Questionnaire
timeFrame: This parameter will be examined at baseline.
measure: Inflammatory Bowel Disease Quality of Life Questionnaire
timeFrame: This parameter will be examined at 6 weeks.
Secondary outcomes:
measure: Simple clinical colitis activity index
timeFrame: This parameter will be examined at baseline.
measure: Simple clinical colitis activity index
timeFrame: This parameter will be examined at 6 weeks.
measure: Hospital anxiety and depression scale
timeFrame: This parameter will be examined at baseline.
measure: Hospital anxiety and depression scale
timeFrame: This parameter will be examined at 6 weeks.
measure: European Quality of Life Scale
timeFrame: This parameter will be examined at baseline.
measure: European Quality of Life Scale
timeFrame: This parameter will be examined at 6 weeks.
measure: International Physical Activity Questionnaire - Short Form
timeFrame: This parameter will be examined at baseline.
measure: International Physical Activity Questionnaire - Short Form
timeFrame: This parameter will be examined at 6 weeks.
measure: IBD Fatigue Scale
timeFrame: This parameter will be examined at baseline
measure: IBD Fatigue Scale
timeFrame: This parameter will be examined at 6 weeks
measure: Gut bacteria and fungi Gut bacteria and fungi
timeFrame: This parameter will be examined at baseline
measure: Gut bacteria and fungi
timeFrame: This parameter will be examined at 6 weeks.
measure: TNF alpha
timeFrame: This parameter will be examined at baseline
measure: TNF alpha
timeFrame: This parameter will be examined at 6 weeks.
measure: Interleukin-6
timeFrame: This parameter will be examined at baseline
measure: Interleukin-6
timeFrame: This parameter will be examined at 6 weeks.
measure: Interleukin-17A
timeFrame: This parameter will be examined at baseline
measure: Interleukin-17A
timeFrame: This parameter will be examined at 6 weeks.
measure: Interleukin-12
timeFrame: This parameter will be examined at baseline
measure: Interleukin-12
timeFrame: This parameter will be examined at 6 weeks.
measure: Interleukin-23
timeFrame: This parameter will be examined at baseline
measure: Interleukin-23
timeFrame: This parameter will be examined at 6 weeks.
measure: Interleukin-10
timeFrame: This parameter will be examined at baseline
measure: Interleukin-10
timeFrame: This parameter will be examined at 6 weeks.
measure: Transforming growth factor Beta
timeFrame: This parameter will be examined at baseline
measure: Transforming growth factor Beta
timeFrame: This parameter will be examined at 6 weeks
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
city: London
country: United Kingdom
facility: University of Hertfordshire
Study officials:
References: