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

Sponsor

University of Kiel (Other)

Overall Status

Recruiting

CT.gov ID

NCT04598022

Collaborator

(none)

120

Enrollment

Location

62.9

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: cross-sectional observation Other: cross-sectional follow-up observation

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

change in body weight [one year]
change in body weight
change in fat mass [one year]
change in body composition

Secondary Outcome Measures

saliva metabolome [one year]
changes in saliva metabolome
gut microbiome [one year]
changes in gut microbiome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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