Impact of the Novel UC-TREAT Diet on the Gut Microbiome and Its Acceptability in Healthy Adults and Adults With Quiescent Ulcerative Colitis
NCT ID: NCT06998277
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2024-05-08
2026-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adults with quiescent Ulcerative Colitis
Adults with Ulcerative Colitis currently in remission (SCCAI ≤ 5)
Dietary therapy
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
Healthy controls
Healthy adults (≥ 16y)
Dietary therapy
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.
Interventions
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Dietary therapy
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
Dietary therapy
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.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of Ulcerative Colitis
* ≥16 years of age
* Motivated to follow the prescribed diet for the study period
Healthy controls:
* ≥16 years of age
* Motivated to follow the prescribed diet for the study period
Exclusion Criteria
* Self-reported active disease (SCCAI≥5) and/or a score ≥2 on any variable within SCCAI
* Previous surgery related to their UC (e.g. colectomy)
* Adjustment of medication dose in the previous month
* Initiation of a new medication in the prior 3 months
* BMI≥35kg/m2
* Pregnancy or lactation
* Regular use of pre/probiotic supplements
* Antibiotics or steroid use in the past 2 months
* Weight fluctuations ≥ 2kg in the past month
* Dietary restrictions (vegetarian, vegan, gluten-free etc)
* Participation in other interventional research.
Healthy controls:
* Regular use of medication or regular visits to a physician
* History of gut surgery
* BMI≥35kg/m2
* Pregnancy or lactation
* Regular use of pre/probiotic supplements
* Antibiotics or steroid use in the past 2 months
* Weight fluctuations ≥ 2kg in the past month
* Dietary restrictions (vegetarian, vegan, gluten-free etc)
* Participation in other interventional research.
16 Years
ALL
Yes
Sponsors
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University of Glasgow
OTHER
Responsible Party
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Dr Konstantinos Gerasimidis
Professor
Principal Investigators
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Konstantinos Gerasimidis
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Athanasios Koutsos
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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University of Glasgow
Glasgow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UC-TREAT
Identifier Type: -
Identifier Source: org_study_id
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