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

Healthy Clinical Trial

— Freshman  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598022
• Other study ID #: ABW-2020-HM
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: University of Kiel
• Contact: Anja Bosy-Westphal, PhD, MD
• Phone: +494318805674
• Email: abosyw[@]nutrition.uni-kiel.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• cross-sectional observation
observation of dietary patterns, body weight status, microbiome and metabolome profiles at the start of the first semester
• cross-sectional follow-up observation
follow-up observation of dietary patterns, body weight status,microbiome and metabolome profiles after one year

Locations

Country	Name	City	State
Germany	Institute of Human Nutrition	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in body weight	change in body weight	one year
Primary	change in fat mass	change in body composition	one year
Secondary	saliva metabolome	changes in saliva metabolome	one year
Secondary	gut microbiome	changes in gut microbiome	one year