The Exploration of the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults

Sponsor
The Seventh Affiliated Hospital, Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05597137
Collaborator
(none)
60
1
1
15
4

Study Details

Study Description

Brief Summary

In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-magnesium diet for 1-3 weeks and take Zinc supplements for 4-6 weeks

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Zinc Gluconate
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
To Explore the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

During the study period, all subjects were required to avoid a diet high in zinc in order to avoid interference with dietary zinc intake and reduce bias. In weeks 4-6, all subjects were started to receive zinc supplementation at the normal adult dose (zinc tablets: 1 tablet (50mg) once daily after meals), while maintaining the avoidance of high-zinc foods.

Dietary Supplement: Zinc Gluconate
Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.

Outcome Measures

Primary Outcome Measures

  1. 16S rDNA sequencing [42 days]

    16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after Zinc supplementation.

  2. metabolomic analysis of serum and feces [42 days]

    To determine the alteration of gut microbiota after Zn supplementary.

Secondary Outcome Measures

  1. The serum levels of Zn2+ in each study phase [42 days]

    The serum levels of Zn2+ would be detected on day 0, day 21 and day 42.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy adults aged 20-30 years from the general community were recruited to participate in the study voluntarily without underlying diseases.
Exclusion Criteria:

Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation; Those who have taken hormones within 3 months; Have taken any drugs that may interfere with glucose and lipid metabolism (such as insulin, glyburide, indomethacin, phentolamine, fuuside, phenytoin sodium, cortisone, etc.) and have had probiotic intervention within 1 month; smokers and drinkers; Uncontrollable mental disorders (including hospitalization history of mental illness); (6) Currently attending a weight loss or weight management course; prescribed diet for specific or other reasons (e.g. celiac disease); pregnant or lactating women; Patients with cardiac and renal insufficiency; Patients with other underlying diseases; Long-term constipation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southern Medical Unversity,the seventh affiliated hospital Foshan Guangdong China 528000

Sponsors and Collaborators

  • The Seventh Affiliated Hospital, Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Yu Chen, chief physician, The Seventh Affiliated Hospital, Southern Medical University
ClinicalTrials.gov Identifier:
NCT05597137
Other Study ID Numbers:
  • (2022)--0008
First Posted:
Oct 27, 2022
Last Update Posted:
Nov 10, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu Chen, chief physician, The Seventh Affiliated Hospital, Southern Medical University

Study Results

No Results Posted as of Nov 10, 2022