Revealing Microbiome Association With (Plant-based) Diet in Freshman
Freshman
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
April 29, 2026
April 1, 2026
7.2 years
October 16, 2020
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change in body weight
change in body weight
one year
change in fat mass
change in body composition
one year
Secondary Outcomes (2)
saliva metabolome
one year
gut microbiome
one year
Study Arms (3)
vegan
subjects having a vegan nutrition pattern for at least the last 3 months
vegetarian
subjects having a vegetarian nutrition pattern for at least the last 3 months
omnivores
subjects having a omnivore nutrition pattern for at least the last 3 months
Interventions
observation of dietary patterns, body weight status, microbiome and metabolome profiles at the start of the first semester
follow-up observation of dietary patterns, body weight status,microbiome and metabolome profiles after one year
Eligibility Criteria
healthy university / college freshmen studying in Kiel, Germany
You may qualify if:
- freshman
- following a vegan / vegetarian / omnivore dietary pattern for at least 3 months
- own a smartphone (including internet access and camera)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Human Nutrition
Kiel, 24105, Germany
Biospecimen
serum and plasma samples, saliva, urine and stool samples
Study Officials
- PRINCIPAL INVESTIGATOR
Anja Bosy-Westphal, PhD, MD
Institute of Human Nutrition, Kiel University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Anja Bosy-Westphal, PhD, MD
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
October 1, 2020
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04