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Health Benefits of Tart Cherry in Ulcerative Colitis

U

University of Central Lancashire

Status

Completed

Conditions

Ulcerative Colitis

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Montmorency tart cherry

Study type

Interventional

Funder types

Other

Identifiers

NCT05486507
Tart cherry ulcerative colitis

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Montmorency tart cherry juice
Experimental group
Treatment:
Dietary Supplement: Montmorency tart cherry
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

2

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Central trial contact

Jonathan Sinclair

Data sourced from clinicaltrials.gov

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