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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597137
• Other study ID #: (2022)--0008
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2023
• Source: The Seventh Affiliated Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Zinc Gluconate
Each participant should receive a regular zinc diet for weeks 1-2 and take zinc supplements for weeks 3-4.

Locations

Country	Name	City	State
China	Southern Medical Unversity,the seventh affiliated hospital	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Seventh Affiliated Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	metabolomic analysis of serum and feces	To determine the alteration of gut microbiota after Zn supplementary.	14days,28 days
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	albumin concentration after 14days oral Zn.	change from 14days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.	14days,28 days
Secondary	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
Secondary	Urea concentration after 14days oral Zn.	change from 14days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.	14days,28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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