Fermented Vegan Optimized Diet in Health and Colitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

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. 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. a. The same design as in 1a but with comparison between a regular meat-based diet and a diet with vegetarian meat substitutes instead.

2b. The same design as I 2a but with IBD patients. Healthy volunteers will be invited wit advertisements. The IBD patients will be recruited at the out-patient clinic at the Dept of Gastroenterology at Skåne university hospital, Sweden. Before inclusion their disease activity will be monitored.

The study is a prospective non-randomized intervention study including both men and women. Each individual will serve as their own control. The meals based on meat substitutes will be composed in cooperation with a dietitian. The estimated amount of yogurt is 200-250 gram/day, and the amount of meat is 150-200 gram/day.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers in two groups

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

Disqualifiers

For healthy any disease requiring medication

For IBD previous extensive operation

For both antibiotics the past month

Trial design

Design model

Sequential

Treatments tested in this trial

  • Vegetarian yogurt

    Dietary supplement

    Vegetarian yogurt alternative will be uesd.

  • Placebo

    Dietary supplement

    Ordinary diet with dairy based yogurt

  • Vegetarian meat alternative

    Dietary supplement

    Vegetarian meat alternative consumed

  • Ordinary meat diet

    Dietary supplement

    Ordinary meat diet used as placebo

Treatment groups

240 Participants
are divided into 4 treatment groups
Group A: Vegetarian yogurt alternativeActive comparator 1 intervention
Group B: Placebo: Ordinary yogurt based dietPlacebo comparator 1 intervention
Group C: Vegetarian meat alternativeActive comparator 1 intervention
Group D: Placebo - ordinary meat dietPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Four weeks

Secondary outcomes

1

Barrier integrity

The barrier function will be estimated by analysing the presence of bacterial DNA in blood. The health promoting effect of the diet on barrier integrity will be estimated with analysis of the amount of bacterial DNA in the blood stream. Since this ia a study investigating new findings based on one previous article it is not possible to state any specific cut-off value. .

Time frame
Four weeks

Other outcomes

Sponsors and contacts

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