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

Study Overview
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Brief Summary
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Zinc Gluconate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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) once daily after meals), while maintaining the avoidance of high-zinc foods. | Dietary Supplement: Zinc Gluconate<br>* Each participant should receive a regular zinc diet for weeks 1-2 and take zinc supplements for weeks 3-4.<br>|

What is the study measuring?
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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 | 
| The serum levels of Zn2+ in each study phase | The serum levels of Zn2+ would be detected on day 0, 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 | 

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 | 
| Urea concentration after 14days oral Zn. | change from 14days in urea and analyzed by the AU5800 fully automatic biochemical analyzer. | 14days，28 days | 
| HDL-C concentration after 14days oral Zn. | change from 14days 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 14days in LDC-C(low density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic | 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 | 
| Plateltes analysis after 14days oral Zn. | change from 14days in Plateltes 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 | 
| Basophil cells analysis after 14days oral Zn. | change from 14days 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 14days 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 14days in Monocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser. | 14days，28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc, gut microbiota, healthy adult