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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05597137
Enrollment
56
Registered
2022-10-27
Start date
2023-03-01
Completion date
2023-08-01
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Zinc, gut microbiota, healthy adult

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.

Interventions

DIETARY_SUPPLEMENTZinc Gluconate

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

Sponsors

The Seventh Affiliated Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
16S rDNA sequencing14days,28 days16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after Zinc supplementation.
metabolomic analysis of serum and feces14days,28 daysTo determine the alteration of gut microbiota after Zn supplementary.
The blood levels of Zn2+ in each study phase14days,28 daysThe blood levels of Zn2+ would be detected on day 14 and day 28.
Number of participantswith abnormal laboratory tests results14days,28 daysIf 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 phase14days,28 daysThe fecal Zn2+ concentration would be detected on day 14 and day 28.

Secondary

MeasureTime frameDescription
total protein concentration after 14days oral Zn.14days,28 dayschange from 14days in total protein and analyzed by the AU5800 fully automatic biochemical analyzer.
aspartate transaminase concentration after 14days oral Zn.14days,28 dayschange from 14days in aspartate transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.
alanine transaminase concentration after 14days oral Zn.14days,28 dayschange from 14days in alanine transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.
albumin concentration after 14days oral Zn.14days,28 dayschange from 14days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.
total cholesterol concentration after 14days oral Zn.14days,28 dayschange from 14days in total cholesterol and analyzed by the AU5800 fully automatic biochemical analyzer.
Urea concentration after 14days oral Zn.14days,28 dayschange from 14 days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.
HDL-C concentration after 14days oral Zn.14days,28 dayschange 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 dayschange from 14 days in LDC-C(low density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic
Total bilirubin concentration after 14days oral Zn.14days,28 dayschange from 14days in Total bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Plateltes analysis after 14days oral Zn.14days,28 dayschange 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 dayschange 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 dayschange 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 dayschange 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 dayschange 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 dayschange 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 dayschange from 14 days in white blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Red blood cells analysis after 14days oral Zn.14days,28 dayschange from 14days in Red blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.
Direct bilirubin concentration after 14days oral Zn.14days,28 dayschange from 14days in Direct bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Indirect bilirubin concentration after 14days oral Zn.14days,28 dayschange from 14days in indirect bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
uric acid concentration after 14days oral Zn.14days,28 dayschange from 14days in uric acid and analyzed by the AU5800 fully automatic biochemical analyzer.
total triglyceride concentration after 14days oral Zn.14days,28 dayschange from 14days in total triglyceride and analyzed by the AU5800 fully automatic biochemical analyzer.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026