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Not yet recruiting NCT07003230

Effect of Vegan Diet on Microbiome and Metabolism

No phase Interventional Vegan Diet

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vegan and omnivorous diet.
Who it may be relevant to
Registry conditions: Vegan Diet. Basic parameters: 20 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Dietary supplement vegan and omnivorous diet
    Participants underwent a 2-week omnivorous diet intervention, followed by a 2-week vegan diet intervention

Primary outcome measures

  • Gut microbiota composition in twenty participants [Time frame: 14days，28days]
Secondary outcome measures (1)
  • Metabolomic profile of twenty participants in serum and feces [Time frame: 14days, 28days]

Eligibility criteria

Inclusion Criteria: healthe Participants, ages 20-30 years old

Exclusion criteria

  • 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;
  • Following a special or medically prescribed diet (e.g., for celiac disease);
  • Comorbid cardiac or renal insufficiency;
  • Chronic constipation;
  • Hypertension;
  • Diabetes mellitus.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

China · 1 center
  • Zhujiang hospital — Guangzhou

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. PMID 38291301

Identifiers

NCT: NCT07003230 · 32271230

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗