Recruiting NCT04598022
Revealing Microbiome Association With (Plant-based) Diet in Freshman
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cross-sectional observation, cross-sectional follow-up observation.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Aim of the study is to evaluate the impact of a vegan vs. vegetarian dietary pattern compared to an omnivore diet on body weight, saliva and stool microbiome profiles, as well as saliva, urine and plasma metabolome profile changes in freshmen after the first year at university/college.
Interventions
- Other cross-sectional observation
observation of dietary patterns, body weight status, microbiome and metabolome profiles at the start of the first semester - Other cross-sectional follow-up observation
follow-up observation of dietary patterns, body weight status,microbiome and metabolome profiles after one year
Primary outcome measures
- change in body weight [Time frame: one year]
- change in fat mass [Time frame: one year]
Secondary outcome measures (2)
- saliva metabolome [Time frame: one year]
- gut microbiome [Time frame: one year]
Eligibility criteria
Inclusion criteria
- freshman
- following a vegan / vegetarian / omnivore dietary pattern for at least 3 months
- own a smartphone (including internet access and camera)
Exclusion criteria
- regular use of medication (excluding oral contraceptiva)
- use of antibiotics in the last 6 weeks
- chronic disease, especially gut diseases
- following a vegan / vegetarian / omnivore dietary pattern for less then 3 months
- no clear assignment of vegan / vegetarian / omnivore dietary pattern
- electrical implants
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Institute of Human Nutrition — Kiel
Identifiers
NCT: NCT04598022 · ABW-2020-HM