Clinical trial NCT05597137: The Exploration of the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults
Official title: To Explore the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Zinc, gut microbiota, healthy adult
Lead sponsor: The Seventh Affiliated Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 16S rDNA sequencing
timeFrame: 14days，28 days
measure: metabolomic analysis of serum and feces
timeFrame: 14days，28 days
measure: The blood levels of Zn2+ in each study phase
timeFrame: 14days，28 days
measure: Number of participantswith abnormal laboratory tests results
timeFrame: 14days，28 days
measure: The fecal Zn2+ concentration in each study phase
timeFrame: 14days，28 days
Secondary outcomes:
measure: Total bilirubin concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: Direct bilirubin concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: Indirect bilirubin concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: uric acid concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: total triglyceride concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: total protein concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: aspartate transaminase concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: alanine transaminase concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: albumin concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: total cholesterol concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: Urea concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: HDL-C concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: LDL-C concentration after 14days oral Zn.
timeFrame: 14days，28 days
measure: Red blood cells analysis after 14days oral Zn.
timeFrame: 14days，28 days
measure: Plateltes analysis after 14days oral Zn.
timeFrame: 14days，28 days
measure: Neutrophil cells analysis after 14days oral Zn.
timeFrame: 14days，28 days
measure: Eosinophil cells analysis after 14days oral Zn.
timeFrame: 14days，28 days
measure: Basophil cells analysis after 14days oral Zn.
timeFrame: 14days，28 days
measure: Lymphocyte cells analysis after 14days oral Zn.
timeFrame: 14days，28 days
measure: Monocyte cells analysis after 14days oral Zn.
timeFrame: 14days，28 days
measure: White blood cells analysis after 14days oral Zn.
timeFrame: 14days，28 days
Other outcomes:
Locations:
city: Foshan
country: China
facility: Southern Medical Unversity，the seventh affiliated hospital
state: Guangdong
Study officials:
References:
citation: 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.