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
1
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. change in body weight [one year]

    change in body weight

  2. change in fat mass [one year]

    change in body composition

Secondary Outcome Measures

  1. saliva metabolome [one year]

    changes in saliva metabolome

  2. 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Institute of Human NutritionKielGermany24105

Sponsors and Collaborators

  • University of Kiel

Investigators

  • Principal Investigator: Anja Bosy-Westphal, PhD, MD, Institute of Human Nutrition, Kiel University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Dr. Anja Bosy-Westphal, Prof. Anja Bosy-Westphal, PhD, MD, University of Kiel
ClinicalTrials.gov Identifier:
NCT04598022
Other Study ID Numbers:
  • ABW-2020-HM
First Posted:
Oct 22, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Dr. Dr. Anja Bosy-Westphal, Prof. Anja Bosy-Westphal, PhD, MD, University of Kiel

Study Results

No Results Posted as of Oct 8, 2021