Crohn Disease (CD)NCT06901986
Health Benefits of Tart Cherry in Crohn's Disease
A study testing Montmorency tart cherry in people with Crohn Disease (CD), run by University of Central Lancashire.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Montmorency tart cherry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults with Mild to Moderate 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.
Read more
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.
- Conditions
- Crohn Disease (CD)
- Being tested
- Montmorency tart cherry, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montmorency tart cherryDietary supplement
Montmorency tart cherry 60ml per day for 6 weeks.
PlaceboDietary supplement
Taste matched placebo.
| Study group | Role | What they receive |
|---|---|---|
| Montmorency tart cherry juice | Experimental | Dietary Supplement: Montmorency tart cherry Description: US grown Montmorency tart cherry 60ml per day for 6 weeks. Receives: Dietary Supplement: Montmorency tart cherry |
| Placebo | Placebo comparator | Taste matched placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: This parameter will be examined at baseline.
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).
Measured: This parameter will be examined at 6 weeks
Secondary outcomes (12)
Simple clinical colitis activity index
The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.
Measured: This parameter will be examined at baseline.
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.
Measured: This parameter will be examined at 6 weeks
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.
Measured: This parameter will be examined at baseline.
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.
Measured: This parameter will be examined at 6 weeks
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.
Measured: This parameter will be examined at baseline.
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.
Measured: This parameter will be examined at 6 weeks
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.
Measured: This parameter will be examined at baseline
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.
Measured: This parameter will be examined at 6 weeks
Faecal calprotectin
Faecal calprotectin is a stool test that measures the protein calprotectin, released by neutrophils during inflammation, to assess gut inflammation.
Measured: This parameter will be examined at baseline
Faecal calprotectin
Faecal calprotectin is a stool test that measures the protein calprotectin, released by neutrophils during inflammation, to assess gut inflammation.
Measured: This parameter will be examined at 6 weeks
Gut microbiome
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.
Measured: This parameter will be examined at baseline
Faecal calprotectin
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.
Measured: This parameter will be examined at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hertfordshire
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901986
- Sponsor's protocol ID
- Tart cherry Crohn's disease
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults with Mild to Moderate Crohn's Disease.
- ClinicalTrials.gov ID
- NCT06901986
- Acronym / sponsor ID
- Tart cherry Crohn's disease
- Conditions
- Crohn Disease (CD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- University of Hertfordshire
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montmorency tart cherry juice | Experimental | Dietary Supplement: Montmorency tart cherryDietary Supplement: Montmorency tart cherry Description: US grown Montmorency tart cherry 60ml per day for 6 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTaste matched placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Diabetes
- HIV
- Hepatitis B and C infection
- Abscesses
- Unstable medical conditions that would likely prevent the subject from completing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montmorency tart cherryMontmorency tart cherry 60ml per day for 6 weeks. | Dietary supplement | Montmorency tart cherry juice |
| PlaceboTaste matched placebo. | Dietary supplement | Placebo |
Primary outcome
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).
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).
12 secondary outcomes
Simple clinical colitis activity index
Time frame: This parameter will be examined at baseline.
Hospital anxiety and depression scale
Time frame: This parameter will be examined at 6 weeks
European Quality of Life Scale
Time frame: This parameter will be examined at baseline.
European Quality of Life Scale
Time frame: This parameter will be examined at 6 weeks
International Physical Activity Questionnaire - Short Form
Time frame: This parameter will be examined at baseline.
International Physical Activity Questionnaire - Short Form
Time frame: This parameter will be examined at 6 weeks
IBD Fatigue Scale
Time frame: This parameter will be examined at baseline
IBD Fatigue Scale
Time frame: This parameter will be examined at 6 weeks
Faecal calprotectin
Time frame: This parameter will be examined at baseline
Faecal calprotectin
Time frame: This parameter will be examined at 6 weeks
Gut microbiome
Time frame: This parameter will be examined at baseline
Faecal calprotectin
Time frame: This parameter will be examined at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Montmorency tart cherry in people with Crohn Disease (CD), run by University of Central Lancashire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Sinclair, DSc, PhD (+447875651533, jksinclair@uclan.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Bowel Disease Quality of Life Questionnaire (time frame: This parameter will be examined at baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.