Ulcerative ColitisNCT05486507
Health Benefits of Tart Cherry in Ulcerative Colitis
A study testing Montmorency tart cherry in people with Ulcerative Colitis, run by University of Central Lancashire at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Montmorency tart cherry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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.
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
2 sites in 1 country.
United Kingdom2 sites
University of Hertfordshire
London
University of Central Lancashire
Preston, Lancashire, PR1 2HE
About this study
Official title: The Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults With Mild to Moderate Ulcerative Colitis; a Placebo Randomized Control Trial
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Montmorency tart cherry, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montmorency tart cherryDietary supplement
US grown 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 | Not described Receives: Dietary Supplement: Montmorency tart cherry |
| Placebo | Placebo comparator | Not described 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 (26)
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.
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 6 weeks.
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 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
Gut bacteria and fungi Gut bacteria and fungi
Gut bacteria and fungi will be measured from feacal samples with higher values indicating greater levels of bacteria and fungi in the gut.
Measured: This parameter will be examined at baseline
Gut bacteria and fungi
Gut bacteria and fungi will be measured from feacal samples with higher values indicating greater levels of bacteria and fungi in the gut.
Measured: This parameter will be examined at 6 weeks.
TNF alpha
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at baseline
TNF alpha
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at 6 weeks.
Interleukin-6
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at baseline
Interleukin-6
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at 6 weeks.
Interleukin-17A
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at baseline
Interleukin-17A
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at 6 weeks.
Interleukin-12
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at baseline
Interleukin-12
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at 6 weeks.
Interleukin-23
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at baseline
Interleukin-23
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at 6 weeks.
Interleukin-10
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at baseline
Interleukin-10
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at 6 weeks.
Transforming growth factor Beta
This measure will be obtained from blood samples to provide a measure of inflammation.
Measured: This parameter will be examined at baseline
Transforming growth factor Beta
This measure will be obtained from blood samples to provide a measure of inflammation.
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 posted3 Aug 2022
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- 40 participants (actual)
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
- NCT05486507
- Sponsor's protocol ID
- Tart cherry ulcerative colitis
- Status last verified
- Jan 2025
- First submitted
- 31 Jul 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults With Mild to Moderate Ulcerative Colitis; a Placebo Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05486507
- Acronym / sponsor ID
- Tart cherry ulcerative colitis
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- University of Hertfordshire
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 3 Aug 2022 (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.
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.
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 cherry |
| Placebo | Placebo comparator | Dietary Supplement: 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 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.
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 cherryUS grown Montmorency 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).
26 secondary outcomes
Simple clinical colitis activity index
Time frame: This parameter will be examined at baseline.
Simple clinical colitis activity index
Time frame: This parameter will be examined at 6 weeks.
Hospital anxiety and depression scale
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
Gut bacteria and fungi Gut bacteria and fungi
Time frame: This parameter will be examined at baseline
Gut bacteria and fungi
Time frame: This parameter will be examined at 6 weeks.
TNF alpha
Time frame: This parameter will be examined at baseline
TNF alpha
Time frame: This parameter will be examined at 6 weeks.
Interleukin-6
Time frame: This parameter will be examined at baseline
Interleukin-6
Time frame: This parameter will be examined at 6 weeks.
Interleukin-17A
Time frame: This parameter will be examined at baseline
Interleukin-17A
Time frame: This parameter will be examined at 6 weeks.
Interleukin-12
Time frame: This parameter will be examined at baseline
Interleukin-12
Time frame: This parameter will be examined at 6 weeks.
Interleukin-23
Time frame: This parameter will be examined at baseline
Interleukin-23
Time frame: This parameter will be examined at 6 weeks.
Interleukin-10
Time frame: This parameter will be examined at baseline
Interleukin-10
Time frame: This parameter will be examined at 6 weeks.
Transforming growth factor Beta
Time frame: This parameter will be examined at baseline
Transforming growth factor Beta
Time frame: This parameter will be examined at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montmorency tart cherry in people with Ulcerative Colitis, run by University of Central Lancashire at 2 sites in United Kingdom.
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: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 24 Jan 2025.