Fermented Vegan Optimized Diet in Health and Colitis

NCT06696222 | Recruiting

• 1 other identifier: 2024-05870 FAVORIT
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

The diet is assumed to contribute to many of our present non-communicable diseases. Vegetarian products are instead considered to be health promoting, However, it is not verified that the modern vegetarian and vegan products are healthier than the ones they are meant to replace. Products based on vegetables are nowadays often produced with advanced techniques and can therefore differ substantially from the original vegetables. The epithelium in the gut is protected by a mucus layer that efficiently prevents bacteria to encounter the epithelium and even to translocate into the gut and the blood stream. In several inflammatory conditions such as e.g., inflammatory bowel disease (IBD) the barrier integrity is disrupted, and translocation will occur. Fibers are important for the gut microbiota enabling the production of short chain fatty acids (SCFA) that is necessary as nutrition for the epithelial cells, Fibers also promote the development of mucus. The aim of the present study is to evaluate components in the diet that is claimed to be health promoting even though they sometimes can be a hazard to your health. Both fibers and antinutrients can be found in these dietary regimens. The health effects of these products will be studied by analysis of the gut microbiota and the barrier integrity as markers of the health status. Gut microbiota will be analyzed with next generation sequencing and q-PCR (polymerase chain reaction). Diversity and the occurrence of different species will be determined. The barrier integrity will be estimated by analysis of bacterial DNA in blood and presence of live bacteria. The study consists of two different parts: 1a. 60 health volunteers are divided into two groups. One group consumes ordinary dairy based yogurt and the other a yogurt based on vegan products for four weeks to enable a change in the gut microbiota. At start and after four weeks fecal samples and questionnaires about the general health and gastrointestinal symptoms will be retrieved. It should be noted that the compounds offered can be bought in the ordinary shops.

1. 1.b. The same design as above but with IBD patients instead. Their disease activity will be monitored by scoring sheets and regular blood tests as a part of their regular check-up.
2. 2.a. The same design as in 1a but with comparison between a regular meat-based diet and a diet with vegetarian meat substitutes instead.

Conditions

Healthy Volunteers; Inflammatory Bowel Disease (IBD)

Keywords

diet; ulcerative colitis; Crohn's disease; vegetarian diet

Outcome Measures

Primary Outcomes (1)

• Diversity and microbial composition

  Gut microbiota will be analyzed at start and after four weeks. The health promoting efect of the diet will be estimated with analysis of the alfa and beta diversity as well as microbila composition down to species level to determine the balance betweedn beneficial and harmful species. Based on the complexity of the micorbiota it is not possible to state any specific value that should be achieved.

  Four weeks

Secondary Outcomes (1)

• Barrier integrity

  Four weeks

Study Arms (4)

Vegetarian yogurt alternative

ACTIVE COMPARATOR

Participants will consume vegatarian based alternatives instead of ordinary yogurt.

Dietary Supplement: Vegetarian yogurt

Placebo: Ordinary yogurt based diet

PLACEBO COMPARATOR

Participants will consume regular yogurt.

Dietary Supplement: Placebo

Vegetarian meat alternative

ACTIVE COMPARATOR

The participants will consume a vegetarian alternative to meat.

Dietary Supplement: Vegetarian meat alternative

Placebo - ordinary meat diet

PLACEBO COMPARATOR

The participants will consume an ordinary meat based diet.

Dietary Supplement: Ordinary meat diet

Interventions

Vegetarian yogurt DIETARY_SUPPLEMENT

Vegetarian yogurt alternative will be uesd.

Vegetarian yogurt alternative

Placebo DIETARY_SUPPLEMENT

Ordinary diet with dairy based yogurt

Placebo: Ordinary yogurt based diet

Vegetarian meat alternative DIETARY_SUPPLEMENT

Vegetarian meat alternative consumed

Vegetarian meat alternative

Ordinary meat diet DIETARY_SUPPLEMENT

Ordinary meat diet used as placebo

Placebo - ordinary meat diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers in two groups
• IBD in two groups (ulcerative colitis or Crohn's disease)

You may not qualify if:

• For healthy any disease requiring medication
• For IBD previous extensive operation
• For both antibiotics the past month

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Dept of Gastroenterology

Malmo, 21428, Sweden

RECRUITING

Dept of Gastroenterology

Malmo, 21428, Sweden

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Klas Sjöberg, Adj prof

  Dept of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klas Sjöberg, Adj prof

CONTACT

+46 40 33 61 61; klas.sjoberg@med.lu.se

Åsa Håkansson, Associate prof

CONTACT

+46 46 222 83 26; asa.hakansson@ple.lth.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective non-randomized intevention study where everyone serves as their own control

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 20, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Dcember 31, 2026 until December 31, 2027
• Access Criteria: In order to establish research cooperation.

Locations

SE (2)