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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Zinc Gluconate

• Registration Number: NCT05597137
• Lead Sponsor: The Seventh Affiliated Hospital, Southern Medical University

Brief Summary

In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-Zinc diet for weeks 1-2 and take Zinc supplements for weeks 3-4

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-27
• Study Start: 2023-03-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Zinc Gluconate	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.

Primary Outcome Measures

Name	Time	Method
metabolomic analysis of serum and feces	14days，28 days	To determine the alteration of gut microbiota after Zn supplementary.
The blood levels of Zn2+ in each study phase	14days，28 days	The blood levels of Zn2+ would be detected on day 14 and day 28.
Number of participantswith abnormal laboratory tests results	14days，28 days	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
The fecal Zn2+ concentration in each study phase	14days，28 days	The fecal Zn2+ concentration would be detected on day 14 and day 28.
16S rDNA sequencing	14days，28 days	16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after Zinc supplementation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Southern Medical Unversity，the seventh affiliated hospital; 🇨🇳 Foshan, Guangdong, China