An interventional study of Zinc Gluconate in Healthy, sponsored by The Seventh Affiliated Hospital, Southern Medical University. Completed at 1 site in China. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by The Seventh Affiliated Hospital, Southern Medical University · Not applicable, Interventional, and Basic science
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.
The Seventh Affiliated Hospital, Southern Medical University is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
16S rDNA sequencing
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after Zinc supplementation.
Time frame: 14days，28 days
metabolomic analysis of serum and feces
To determine the alteration of gut microbiota after Zn supplementary.
Time frame: 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.
Time frame: 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
Time frame: 14days，28 days
The fecal Zn2+ concentration in each study phase
The fecal Zn2+ concentration would be detected on day 14 and day 28.
Time frame: 14days，28 days
Total bilirubin concentration after 14days oral Zn.
change from 14days in Total bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14days，28 days
albumin concentration after 14days oral Zn.
change from 14days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.
Time frame: 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.
Time frame: 14days，28 days
Urea concentration after 14days oral Zn.
change from 14 days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14days，28 days
Plan to share: No — 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.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Gluconic acid
The Seventh Affiliated Hospital, Southern Medical University