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NCT Number: NCT06901986

Health Benefits of Tart Cherry in Crohn's Disease

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.

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Key information

Conditions

Crohn Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Montmorency tart cherry

Dietary Supplement

Montmorency tart cherry 60ml per day for 6 weeks.

Placebo

Dietary Supplement

Taste matched placebo.

Primary outcomes

  1. Inflammatory Bowel Disease Quality of Life Questionnaire

    Time frame: This parameter will be examined at baseline.

    The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).

  2. Inflammatory Bowel Disease Quality of Life Questionnaire

    Time frame: This parameter will be examined at 6 weeks

    The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).

Secondary outcomes

  1. Simple clinical colitis activity index

    Time frame: This parameter will be examined at baseline.

    The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.

  2. Hospital anxiety and depression scale

    Time frame: This parameter will be examined at 6 weeks

    The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression.

  3. European Quality of Life Scale

    Time frame: This parameter will be examined at baseline.

    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.

  4. European Quality of Life Scale

    Time frame: This parameter will be examined at 6 weeks

    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.

  5. International Physical Activity Questionnaire - Short Form

    Time frame: This parameter will be examined at baseline.

    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.

  6. International Physical Activity Questionnaire - Short Form

    Time frame: This parameter will be examined at 6 weeks

    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.

  7. IBD Fatigue Scale

    Time frame: This parameter will be examined at baseline

    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.

  8. IBD Fatigue Scale

    Time frame: This parameter will be examined at 6 weeks

    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.

  9. Faecal calprotectin

    Time frame: This parameter will be examined at baseline

    Faecal calprotectin is a stool test that measures the protein calprotectin, released by neutrophils during inflammation, to assess gut inflammation.

  10. Faecal calprotectin

    Time frame: This parameter will be examined at 6 weeks

    Faecal calprotectin is a stool test that measures the protein calprotectin, released by neutrophils during inflammation, to assess gut inflammation.

  11. Gut microbiome

    Time frame: This parameter will be examined at baseline

    The gut microbiome in individuals with IBD differs significantly from that of healthy individuals, with a reduction in beneficial bacteria and an increase in potentially harmful bacteria.

  12. Faecal calprotectin

    Time frame: This parameter will be examined at 6 weeks

    The gut microbiome in individuals with IBD differs significantly from that of healthy individuals, with a reduction in beneficial bacteria and an increase in potentially harmful bacteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Sinclair, DSc, PhD

CONTACT

[email protected]

+447875651533

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Collaborators

  • University of Hertfordshire

Registry information

Official study title

Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults with Mild to Moderate Crohn's Disease.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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