Health Benefits of Tart Cherry in Crohn's Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Central Lancashire

About this trial

Crohn's disease (CD) is a long-term inflammatory condition of the digestive tract. People with CD often experience unpredictable and debilitating symptoms, including abdominal pain, diarrhea, and fatigue. Additionally, they require long-term treatment, which is often associated with frequent negative effects, the need for surgery, and hospitalizations. As a result, individuals with CD report a lower health-related quality of life (HRQOL) compared to healthy individuals.

The most common medication for inflammatory bowel disease is a strong immunosuppressant, which was identified in 2017 as the most expensive medication prescribed in NHS hospitals. Unfortunately, biologics have significant side effects, and reducing the reliance on them could benefit both the NHS by lowering costs and patients by minimizing unwanted side effects.

Supplementation with Montmorency tart cherry juice may offer a simple, safe, and cost-effective intervention for improving symptoms in individuals with CD. This is due to its potential to naturally reduce inflammation in the digestive system, thereby alleviating symptoms. Research in animal models has shown potential improvements in physiological responses with similar supplements, including blueberries, black raspberries, and Montmorency tart cherries, though only one study in human participants has explored bilberry supplementation.

Despite Montmorency tart cherries having superior anthocyanin concentrations compared to other berries, dietary interventions using tart cherry supplementation for CD have not been explored in human participants. The primary aim of the proposed investigation is to conduct a placebo-controlled randomized trial to examine whether Montmorency tart cherry juice supplementation can provide symptom relief and improve health-related well-being in individuals with mild to moderately active CD, as well as to understand the biological mechanisms underlying any observed symptom changes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

An established diagnosis of CDfor 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.

Disqualifiers

Diabetes

HIV

Hepatitis B and C infection

Abscesses

Trial design

Design model

Parallel

Treatments tested in this trial

  • Montmorency tart cherry

    Dietary supplement

    Montmorency tart cherry 60ml per day for 6 weeks.

  • Placebo

    Dietary supplement

    Taste matched placebo.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Montmorency tart cherry juiceExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
This parameter will be examined at baseline.
2

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).

Time frame
This parameter will be examined at 6 weeks

Secondary outcomes

1

Simple clinical colitis activity index

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.
2

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.

Time frame
This parameter will be examined at 6 weeks
3

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.

Time frame
This parameter will be examined at baseline.
4

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.

Time frame
This parameter will be examined at 6 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Central Lancashire

Lead sponsor

University of Hertfordshire

Collaborator

This trial is not recruiting at the moment. You can still explore other options: