Revealing Microbiome Association With (Plant-based) Diet in Freshman (Freshman)

April 28, 2026 updated by: Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

healthy university / college freshmen studying in Kiel, Germany

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
vegan
subjects having a vegan nutrition pattern for at least the last 3 months
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
vegetarian
subjects having a vegetarian nutrition pattern for at least the last 3 months
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
omnivores
subjects having a omnivore nutrition pattern for at least the last 3 months
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in body weight
Time Frame: one year
change in body weight
one year
change in fat mass
Time Frame: one year
change in body composition
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
saliva metabolome
Time Frame: one year
changes in saliva metabolome
one year
gut microbiome
Time Frame: one year
changes in gut microbiome
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kiel

Investigators

  • Principal Investigator: Anja Bosy-Westphal, PhD, MD, Institute of Human Nutrition, Kiel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ABW-2020-HM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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