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NCT Number: NCT04598022

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

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.

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Key information

Conditions

Healthy

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Human Nutrition

Kiel, 24105, Germany

Location status: Recruiting

Location contact

Anja Bosy-Westphal, PhD, MD

CONTACT

[email protected]

+494318805674

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cross-sectional observation

Other

observation of dietary patterns, body weight status, microbiome and metabolome profiles at the start of the first semester

cross-sectional follow-up observation

Other

follow-up observation of dietary patterns, body weight status,microbiome and metabolome profiles after one year

Primary outcomes

  1. change in body weight

    Time frame: one year

    change in body weight

  2. change in fat mass

    Time frame: one year

    change in body composition

Secondary outcomes

  1. saliva metabolome

    Time frame: one year

    changes in saliva metabolome

  2. gut microbiome

    Time frame: one year

    changes in gut microbiome

Study contacts

Contact information is provided by the study sponsor or research team.

Anja Bosy-Westphal, PhD, MD

CONTACT

[email protected]

+494318805674

Sponsors and collaborators

Lead sponsor

University of Kiel

Other

Registry information

Acronym: Freshman

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Oct 22, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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