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This will be an open-label dietary intervention study recruiting both healthy adults (≥16y) and adults with quiescent Ulcerative Colitis (UC). The study will span a total of 25 days and is divided into two phases; a 10-day run-in observation period (day -10 to day 0), during which the participant continues with their normal diet, and a 15-day dietary intervention period (day 0 to day 15), during which they will consume a diet high in specific high-fibre foods, fermented foods, berries, and a multivitamin-multimineral tablet. Throughout the study, participants will be asked to provide 3 blood samples (at days -10, 0, and 15), 4 stool and urine samples (at days -15, 0, 10, and 15), and to record a total of 6 days of food intake in provided food diaries. Disease activity, gastrointestinal symptoms, and quality of life will be assessed on 4 occasions (days -10, 0, 10, and 15) via validated questionnaires, and diet acceptability will be assessed at the end of the study.
This will be an open-label dietary intervention study recruiting both healthy adults (≥16y) and adults with quiescent Ulcerative Colitis (UC) . The study will span a total of 25 days and is divided into two phases; a 10-day "run-in" observational period and a 15-day dietary intervention period.
During the 10-day "run-in" observational period (day -15 to day 0), participants will be asked to continue with their regular habitual diet and record their food intake in a provided estimated weight food diary with food photography for the first 3 of the 10 days. After this "run-in" period, participants will start the 15-day UC-TREAT dietary intervention (day 0 to day 15), where they will consume daily micronutrient supplements, increase intake of berries, and gradually increase intake of dietary fibre and fermented foods.
For the first 5 days of the dietary intervention, participants will enter a "ramping" phase, where, with the guidance of the researchers, they will consume 2 portions of berries (blueberries and raspberries) and 1 multivitamin-multimineral tablet each day. Participants will increase their fibre intake by 1 serving of high-fibre food per day until they reach an additional intake of 35g/d and increase fermented food intake by approximately 1 serving per day until they reach at least 5 servings per day. For the final 10 days of the UC-TREAT dietary intervention, participants will enter a "maintenance phase", where they will maintain this additional 35g of fibre intake and at least 5 servings of fermented foods daily. Participants will be asked to record 3 days of food intake in the provided food diaries during this period. The purpose of the ramping period is to reduce the sudden onset of functional abdominal symptoms typically associated with a rapid increase in dietary fibre consumption, including flatulence, bloating, and abdominal cramping. Throughout the study, participants will be asked to provide 3 blood samples (at days -10, 0 and 15), 4 stool and urine samples (at days -10, 0, 10, and 15), and to record a total of 6 days of food intake in provided food diaries.
On 4 occasions (days -10, 0, 10, and 15), all participants will be asked to complete a questionnaire assessing their gastrointestinal symptoms (GSRS-IBS), while participants with UC will also be asked to complete a questionnaire assessing their disease-specific quality of life (sIBDQ) and self-reported disease activity (SCCAI). At the end of the study (day 15), all participants will also be asked to complete an acceptability questionnaire to assess their tolerance of the diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with quiescent Ulcerative Colitis | Experimental | Adults with Ulcerative Colitis currently in remission (SCCAI ≤ 5) |
|
| Healthy controls | Experimental | Healthy adults (≥ 16y) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary therapy | Other | Participants with quiescent UC will undergo a 10-day "observational" period followed by 15-days of the UC-TREAT dietary intervention. Disease activity, quality of life, and gastrointestinal symptoms will be assessed throughout |
| Measure | Description | Time Frame |
|---|---|---|
| Change in faecal butyrate concentration | Change faecal butyrate concentration at the end of the diet (day 15) compared to baseline (day 0) and control (day -10). | At day -10, day 0, day 10, and day 15 |
| Gastrointestinal symptoms | Change in gastrointestinal symptoms compared to baseline, assessed via the GI Symptom Rating Scale (GSRS-IBS), will be used to assess GI tolerance of the diet. The GSRS-IBS assesses GI symptoms in 5 domains: pain, bloating, constipation, diarrhoea, and satiety, where a score increase indicates symptom increase. | At day -10, day 0, day 10, and day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal metabolites | Targeted faecal metabolites will be assessed via gas chromatography, colorimetry, and NMR metabolomics to evaluate changes to the faecal metabolome throughout the study period | At day -10, day 0, day 10, and day 15. |
| Faecal microbiota diversity |
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Inclusion Criteria:
Individuals with Ulcerative Colitis:
Healthy controls:
Exclusion Criteria:
Individuals with Ulcerative Colitis:
Healthy controls:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Gerasimidis | University of Glasgow | Principal Investigator |
| Athanasios Koutsos | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Glasgow | Glasgow | G31 2ER | United Kingdom |
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Two groups of participants. Adults with ulcerative colitis and healthy adult volunteers; both groups receive the same dietary intervention
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| Dietary therapy | Other | Healthy participants will undergo a 10-day "observational" period, followed by 15-days of the UC-TREAT dietary intervention. Gastrointestinal symptoms will be assessed throughout. |
|
Change in faecal microbiota alpha-diversity during the diet compared to baseline and control. |
| At day -10, day 0, day 10, and day 15 |
| Faecal microbiota composition | Change in faecal microbiota composition (beta-diversity and taxa abundance) during the diet compared to baseline and control, as well as the differences between participants with UC and healthy controls. | At day -10, day 0, day 10, and day 15 |
| Faecal calprotectin | Faecal calprotectin will be measured in all participants to assess any changes in gut inflammation throughout the study. | At day -10, day 0, day 10, and day 15. |
| Blood inflammatory markers | Biomarkers of inflammation in plasma, such as C-reactive protein, will be measured in fasted blood samples. | At day -10, day 0 and day 15. |
| Clinical disease activity | Clinical disease activity will be assessed via the Simple Clinical Colitis Activity Index (SCCAI), where a score increase indicates disease worsening and a score ≥ 5 indicates active disease. | At day -10, day 0, day 10, and day 15. |
| Diet acceptability | Acceptability of the diet will be assessed in all participants at the end of the study, using a study specific 9-item questionnaire employing a 5-point likhert scale ("Strongly Agree", "Agree", "No opinion", "Disagree", "Strongly Disagree"). | Once at the end of the study period (day 15). |
| Quality of life (sIBDQ) | Quality of life will be assessed in participants with Ulcerative Colitis via the short-Inflammatory Bowel Disease Questionnaire (sIBDQ). This questionnaire assesses QoL in 4 domains: bowel, social, emotional, and systemic, where a score increase indicates improve quality of life. | At day -10, day 0, day 10, and day 15. |
| Dietary adherence | Adherence to the prescribed diet will be assessed using daily food checklists. | Throughout the dietary intervention period (~15 days). |
| Dietary intake | Dietary intake will be assessed via 3-day, estimated-portion food diaries supplemented with food photography. Food diaries will be recorded during the observational phase and during the dietary intervention phase of the study. | 3 days on 2 occasions (6 days in total) throughout the entire study period (~25 days). |
| Stool form | Bristol Stool Chart Rating (BSCR) and percentage water content will be assessed to inform of any changes to stool form throughout the study. | At day -10, day 0, day 10, and day 15. |
| Body composition | BMI and %fat mass will be assessed throughout the study to evaluate any changes to body composition throughout the study. | At day -10, day 0 and day 15. |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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