Vegan DietNCT07003230
Effect of Vegan Diet on Microbiome and Metabolism
A study testing vegan and omnivorous diet in people with Vegan Diet, run by Zhujiang Hospital at 1 site in China.
Trial summary
The goal of this interventional study is to investigate how vegan diet affects health in healthy volunteers, Men and women ages 20 - 30 years old. The main questions it aims to answer are: Change in Microbial community composition and metabolic alterations Changes in plasma metabolic profile. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Vegan Diet
- What is being tested?
- vegan and omnivorous diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2025to 31 Dec 2025
- Phase
- Interventional
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Oral antibiotic use or acute/chronic inflammation within the past 3 months;
- Hormone intake within the past 3 months;
- Use of any known interfering medications (e.g., insulin, glibenclamide, indomethacin, phentolamine, furosemide, phenytoin sodium, cortisone, etc.) or probiotics within the past month that may affect glucose or lipid metabolism;
- Smoking or alcohol consumption;
- Uncontrolled mental disorders (including a history of psychiatric hospitalization);
- Currently participating in a weight loss or weight management program;
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- Following a special or medically prescribed diet (e.g., for celiac disease);
- Comorbid cardiac or renal insufficiency;
- Chronic constipation;
- Hypertension;
- Diabetes mellitus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhujiang hospital
Guangzhou, Guangdong, 510515
Zhujiang hospital, zjyygcp@163.com
About this study
The goal of this interventional study is to investigate how vegan diet affects health in healthy volunteers, Men and women ages 20 - 30 years old. The main questions it aims to answer are:
Change in Microbial community composition and metabolic alterations Changes in plasma metabolic profile. Researchers will compare changes in microbiota and plasma metabolites profile to see the influence of vegan diet in health. In the dietary trial, participants were first assigned to a 2-week omnivorous diet phase, then switched to a 2-week vegetarian diet phase
- Conditions
- Vegan Diet
- Being tested
- vegan and omnivorous diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vegan and omnivorous dietDietary supplement
Participants underwent a 2-week omnivorous diet intervention, followed by a 2-week vegan diet intervention
| Study group | Role | What they receive |
|---|---|---|
| Effect of vegan diet on microbiome and metabolism | Experimental | Not described Receives: Dietary Supplement: vegan and omnivorous diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition in twenty participants
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after vegan diet.
Measured: 14days，28days
Secondary outcomes (1)
Metabolomic profile of twenty participants in serum and feces
To determine changes of the metabolomic profile in feces and serum after vegan diet
Measured: 14days, 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start30 May 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vegan DietStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhanguo, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003230
- Sponsor's protocol ID
- 32271230
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Link VM, Subramanian P, Cheung F, Han KL, Stacy A, Chi L, Sellers BA, Koroleva G, Courville AB, Mistry S, Burns A, Apps R, Hall KD, Belkaid Y. Differential peripheral immune signatures elicited by vegan versus ketogenic diets in humans. Nat Med. 2024 Feb;30(2):560-572. doi: 10.1038/s41591-023-02761-2. Epub 2024 Jan 30.
PubMed 38291301
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vegan Diet on Microbiome and Metabolism
- ClinicalTrials.gov ID
- NCT07003230
- Acronym / sponsor ID
- 32271230
- Conditions
- Vegan Diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jun 2025 (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.
The goal of this interventional study is to investigate how vegan diet affects health in healthy volunteers, Men and women ages 20 - 30 years old. The main questions it aims to answer are:
Change in Microbial community composition and metabolic alterations Changes in plasma metabolic profile. Researchers will compare changes in microbiota and plasma metabolites profile to see the influence of vegan diet in health. In the dietary trial, participants were first assigned to a 2-week omnivorous diet phase, then switched to a 2-week vegetarian diet phase
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of vegan diet on microbiome and metabolism | Experimental | Dietary Supplement: vegan and omnivorous diet |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Oral antibiotic use or acute/chronic inflammation within the past 3 months;
- Hormone intake within the past 3 months;
- Use of any known interfering medications (e.g., insulin, glibenclamide, indomethacin, phentolamine, furosemide, phenytoin sodium, cortisone, etc.) or probiotics within the past month that may affect glucose or lipid metabolism;
- Smoking or alcohol consumption;
- Uncontrolled mental disorders (including a history of psychiatric hospitalization);
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 |
|---|---|---|
| vegan and omnivorous dietParticipants underwent a 2-week omnivorous diet intervention, followed by a 2-week vegan diet intervention | Dietary supplement | Effect of vegan diet on microbiome and metabolism |
Primary outcome
Gut microbiota composition in twenty participants
Time frame: 14days，28days
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after vegan diet.
1 secondary outcome
Metabolomic profile of twenty participants in serum and feces
Time frame: 14days, 28days
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 4 Jun 2025.
- Results publication: PubMed 38291301Link VM, Subramanian P, Cheung F, Han KL, Stacy A, Chi L, Sellers BA, Koroleva G, Courville AB, Mistry S, Burns A, Apps R, Hall KD, Belkaid Y. Differential peripheral immune signatures elicited by vegan versus ketogenic diets in humans. Nat Med. 2024 Feb;30(2):560-572. doi: 10.1038/s41591-023-02761-2. Epub 2024 Jan 30.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vegan and omnivorous diet in people with Vegan Diet, run by Zhujiang Hospital at 1 site in China.
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 0 inclusion and 11 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: opening soon, as of the sponsor's last update on 4 Jun 2025. 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 China. 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 Zhanguo Liu (+86 13425766255, zhguoliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition in twenty participants (time frame: 14days，28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07003230, which also lists 1 linked publication.
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 4 Jun 2025.