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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Montmorency tart cherry 60ml per day for 6 weeks.
Taste matched placebo.
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This parameter will be examined at 6 weeks
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