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

To Explore the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Zinc Gluconate

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Southern Medical Unversity，the seventh affiliated hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total bilirubin concentration after 14days oral Zn.	change from 14days in Total bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
Direct bilirubin concentration after 14days oral Zn.	change from 14days in Direct bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
Indirect bilirubin concentration after 14days oral Zn.	change from 14days in indirect bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
uric acid concentration after 14days oral Zn.	change from 14days in uric acid and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
total triglyceride concentration after 14days oral Zn.	change from 14days in total triglyceride and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
total protein concentration after 14days oral Zn.	change from 14days in total protein and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
aspartate transaminase concentration after 14days oral Zn.	change from 14days in aspartate transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
alanine transaminase concentration after 14days oral Zn.	change from 14days in alanine transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
albumin concentration after 14days oral Zn.	change from 14days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
total cholesterol concentration after 14days oral Zn.	change from 14days in total cholesterol and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
Red blood cells analysis after 14days oral Zn.	change from 14days in Red blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.	14days，28 days
Neutrophil cells analysis after 14days oral Zn.	change from 14days in Neutrophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.	14days，28 days
Eosinophil cells analysis after 14days oral Zn.	change from 14days in Eosinophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.	14days，28 days
Urea concentration after 14days oral Zn.	change from 14 days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.	14days，28 days
HDL-C concentration after 14days oral Zn.	change from 14 days in HDL-C(high density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic	14days，28 days
LDL-C concentration after 14days oral Zn.	change from 14 days in LDC-C(low density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic	14days，28 days
Plateltes analysis after 14days oral Zn.	change from 14 days in Plateltes and determined by a Sysmex-xn-2000 automatic blood cell analyser.	14days，28 days
Basophil cells analysis after 14days oral Zn.	change from 14 days in Basophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.	14days，28 days
Lymphocyte cells analysis after 14days oral Zn.	change from 14 days in Lymphocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.	14days，28 days
Monocyte cells analysis after 14days oral Zn.	change from 14 days in Monocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.	14days，28 days
White blood cells analysis after 14days oral Zn.	change from 14 days in white blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.	14days，28 days

Collaborators and Investigators

• Sponsor: The Seventh Affiliated Hospital, Southern Medical University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Zinc, gut microbiota, healthy adult
• Other Study ID Numbers: (2022)--0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No