Effect of Vegan Diet on Microbiome and Metabolism

NCT07003230 | Not Yet Recruiting DMC

• 1 other identifier: 32271230
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  14days，28days

Secondary Outcomes (1)

• Metabolomic profile of twenty participants in serum and feces

  14days, 28days

Study Arms (1)

Effect of vegan diet on microbiome and metabolism

EXPERIMENTAL

Dietary Supplement: vegan and omnivorous diet

Interventions

vegan and omnivorous diet DIETARY_SUPPLEMENT

Participants underwent a 2-week omnivorous diet intervention, followed by a 2-week vegan diet intervention

Effect of vegan diet on microbiome and metabolism

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang hospital

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

• 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. Erratum In: Nat Med. 2024 Jun;30(6):1785. doi: 10.1038/s41591-024-02884-0.

  PMID: 38291301 BACKGROUND

MeSH Terms

Interventions

Diet, Vegan

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Zhanguo Liu

CONTACT

+86 13425766255; zhguoliu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: June 4, 2025
• Study Start: May 30, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)