NCT05597137

Brief Summary

In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-Zinc diet for 2 weeks and then take Zinc supplements for 2 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 24, 2022

Last Update Submit

October 5, 2024

Conditions

Healthy

Keywords

Zinc, gut microbiota, healthy adult

Outcome Measures

Primary Outcomes (5)

  • 16S rDNA sequencing

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

    14days，28 days

  • metabolomic analysis of serum and feces

    To determine the alteration of gut microbiota after Zn supplementary.

    14days，28 days

  • The blood levels of Zn2+ in each study phase

    The blood levels of Zn2+ would be detected on day 14 and day 28.

    14days，28 days

  • Number of participantswith abnormal laboratory tests results

    If there are abnormal situations during the experiment that may pose significant risks to the health or safety of the participants, the research team may need to terminate the experiment to ensure participant safety. Only

    14days，28 days

  • The fecal Zn2+ concentration in each study phase

    The fecal Zn2+ concentration would be detected on day 14 and day 28.

    14days，28 days

Secondary Outcomes (21)

  • Total bilirubin concentration after 14days oral Zn.

    14days，28 days

  • Direct bilirubin concentration after 14days oral Zn.

    14days，28 days

  • Indirect bilirubin concentration after 14days oral Zn.

    14days，28 days

  • uric acid concentration after 14days oral Zn.

    14days，28 days

  • total triglyceride concentration after 14days oral Zn.

    14days，28 days

  • +16 more secondary outcomes

Study Arms (1)

Experimental Group

EXPERIMENTAL

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 the weeks 1-2. In the weeks 3-4, all subjects were started to receive zinc supplementation at the normal adult dose (zinc tablets: 1 tablet (10mg Zinc) once daily after meals), while maintaining the avoidance of high-zinc foods.

Dietary Supplement: Zinc Gluconate

Interventions

Zinc GluconateDIETARY_SUPPLEMENT

Each participant should receive a regular zinc diet for weeks 1-2 and take zinc supplements for weeks 3-4.

Experimental Group

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 20-30 years from the general community were recruited to participate in the study voluntarily without underlying diseases.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Medical Unversity，the seventh affiliated hospital

Foshan, Guangdong, 528000, China

Location

Related Publications (2)

  • Ackland ML, Michalczyk AA. Zinc and infant nutrition. Arch Biochem Biophys. 2016 Dec 1;611:51-57. doi: 10.1016/j.abb.2016.06.011. Epub 2016 Jun 15.

    PMID: 27317042BACKGROUND

  • Li D, Wan M, Xue L, Zhang Z, Qiu Y, Mei F, Tang N, Yu C, Yu Y, Chen T, Ding X, Yang Q, Liu Q, Gu P, Jia W, Chen Y, Chen P. Zinc promotes microbial p-coumaric acid production that protects against cholestatic liver injury. Cell Host Microbe. 2024 Dec 11;32(12):2195-2211.e9. doi: 10.1016/j.chom.2024.11.002. Epub 2024 Nov 27.

    PMID: 39610253DERIVED

Related Links

MeSH Terms

Interventions

gluconic acid

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
chief physician

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 27, 2022

Study Start

March 1, 2023

Primary Completion

June 1, 2023

Study Completion

August 1, 2023

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Since some data may involve subject's privacy #we have no plans to share data so far# and some data may be shared later depending on the subjects's wishes.

Locations

CN(1)