HealthyFreshmanNCT04598022
Revealing Microbiome Association With (Plant-based) Diet in Freshman
An observational study of Healthy, run by University of Kiel at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cross-sectional observation and cross-sectional follow-up observation
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy university / college freshmen studying in Kiel, Germany
Who may be able to join
- freshman
- following a vegan / vegetarian / omnivore dietary pattern for at least 3 months
- own a smartphone (including internet access and camera)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Institute of Human Nutrition
Kiel, 24105
Anja Bosy-Westphal, PhD, MD, +494318805674, abosyw@nutrition.uni-kiel.de
About this study
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.
- Conditions
- Healthy
- Being tested
- cross-sectional observation, cross-sectional follow-up observation
- Keywords
- freshman, vegan, vegetarian, omnivore, microbiome, meal frequency, meal timing, freshman weight gain, metabolome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectional observationOther
observation of dietary patterns, body weight status, microbiome and metabolome profiles at the start of the first semester
cross-sectional follow-up observationOther
follow-up observation of dietary patterns, body weight status,microbiome and metabolome profiles after one year
| Study group | Role | What they receive |
|---|---|---|
| vegan | subjects having a vegan nutrition pattern for at least the last 3 months Receives: Other: cross-sectional observation; Other: cross-sectional follow-up observation | |
| vegetarian | subjects having a vegetarian nutrition pattern for at least the last 3 months Receives: Other: cross-sectional observation; Other: cross-sectional follow-up observation | |
| omnivores | subjects having a omnivore nutrition pattern for at least the last 3 months Receives: Other: cross-sectional observation; Other: cross-sectional follow-up observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight
change in body weight
Measured: one year
change in fat mass
change in body composition
Measured: one year
Secondary outcomes (2)
saliva metabolome
changes in saliva metabolome
Measured: one year
gut microbiome
changes in gut microbiome
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Oct 2020
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel
- Investigators
- Anja Bosy-Westphal, PhD, MD, Principal investigator, Institute of Human Nutrition, Kiel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598022
- Sponsor's protocol ID
- ABW-2020-HM
- Acronym
- Freshman
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealing Microbiome Association With (Plant-based) Diet in Freshman
- ClinicalTrials.gov ID
- NCT04598022
- Acronym / sponsor ID
- Freshman / ABW-2020-HM
- Conditions
- Healthy
- Keywords
- freshman, vegan, vegetarian, omnivore, microbiome, meal frequency, meal timing, freshman weight gain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of KielUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vegan | – | Other: cross-sectional observation, Other: cross-sectional follow-up observationsubjects having a vegan nutrition pattern for at least the last 3 months |
| vegetarian | – | Other: cross-sectional observation, Other: cross-sectional follow-up observationsubjects having a vegetarian nutrition pattern for at least the last 3 months |
| omnivores | – | Other: cross-sectional observation, Other: cross-sectional follow-up observationsubjects having a omnivore nutrition pattern for at least the last 3 months |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy university / college freshmen studying in Kiel, Germany
Key inclusion criteria (3 listed)
- freshman
- following a vegan / vegetarian / omnivore dietary pattern for at least 3 months
- own a smartphone (including internet access and camera)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cross-sectional observationobservation of dietary patterns, body weight status, microbiome and metabolome profiles at the start of the first semester | Other | omnivores, vegan, vegetarian |
| cross-sectional follow-up observationfollow-up observation of dietary patterns, body weight status,microbiome and metabolome profiles after one year | Other | omnivores, vegan, vegetarian |
Primary outcome
change in body weight
Time frame: one year
change in body weight
change in fat mass
Time frame: one year
change in body composition
2 secondary outcomes
saliva metabolome
Time frame: one year
gut microbiome
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anja Bosy-Westphal, PhD, MD principal investigator
Institute of Human Nutrition, Kiel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Kiel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anja Bosy-Westphal, PhD, MD (+494318805674, abosyw@nutrition.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in body weight (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.