Impact of the Novel UC-TREAT Diet on the Gut Microbiome and Its Acceptability in Healthy Adults and Adults With Quiescent Ulcerative Colitis

Last updated: March 4, 2026
Sponsor: University of Glasgow
Overall Status: Completed

Phase

N/A

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Dietary therapy

Clinical Study ID

NCT06998277
UC-TREAT
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Individuals with Ulcerative Colitis:

  • 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

Exclusion Criteria:

Individuals with Ulcerative Colitis:

  • Self-reported active disease (SCCAI≥5) and/or a score ≥2 on any variable withinSCCAI

  • 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.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Dietary therapy
Phase:
Study Start date:
May 08, 2024
Estimated Completion Date:
July 09, 2025

Study Description

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.

Connect with a study center

  • University of Glasgow

    Glasgow, G31 2ER
    United Kingdom

    Site Not Available

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