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

Recruiting

• Conditions: Healthy
• Interventions: Other: cross-sectional observation; Other: cross-sectional follow-up observation

• Registration Number: NCT04598022
• Lead Sponsor: University of Kiel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
omnivores	cross-sectional observation	subjects having a omnivore nutrition pattern for at least the last 3 months
vegan	cross-sectional follow-up observation	subjects having a vegan nutrition pattern for at least the last 3 months
vegetarian	cross-sectional follow-up observation	subjects having a vegetarian nutrition pattern for at least the last 3 months
omnivores	cross-sectional follow-up observation	subjects having a omnivore nutrition pattern for at least the last 3 months
vegan	cross-sectional observation	subjects having a vegan nutrition pattern for at least the last 3 months
vegetarian	cross-sectional observation	subjects having a vegetarian nutrition pattern for at least the last 3 months

Primary Outcome Measures

Name	Time	Method
change in fat mass	one year	change in body composition
change in body weight	one year	change in body weight

Secondary Outcome Measures

Name	Time	Method
saliva metabolome	one year	changes in saliva metabolome
gut microbiome	one year	changes in gut microbiome

Trial Locations

Locations (1)

Institute of Human Nutrition; 🇩🇪 Kiel, Germany