To Explore the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- metabolomic analysis of serum and feces
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 30 Years (Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
metabolomic analysis of serum and feces
Time Frame: 14days，28 days
To determine the alteration of gut microbiota after Zn supplementary.
The blood levels of Zn2+ in each study phase
Time Frame: 14days，28 days
The blood levels of Zn2+ would be detected on day 14 and day 28.
Number of participantswith abnormal laboratory tests results
Time Frame: 14days，28 days
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
The fecal Zn2+ concentration in each study phase
Time Frame: 14days，28 days
The fecal Zn2+ concentration would be detected on day 14 and day 28.
16S rDNA sequencing
Time Frame: 14days，28 days
16S rDNA sequencing technology was used to identify the structural and functional changes of intestinal microbiota before and after Zinc supplementation.
Secondary Outcomes
- Direct bilirubin concentration after 14days oral Zn.(14days，28 days)
- Total bilirubin concentration after 14days oral Zn.(14days，28 days)
- Indirect bilirubin concentration after 14days oral Zn.(14days，28 days)
- uric acid concentration after 14days oral Zn.(14days，28 days)
- total triglyceride concentration after 14days oral Zn.(14days，28 days)
- total protein concentration after 14days oral Zn.(14days，28 days)
- aspartate transaminase concentration after 14days oral Zn.(14days，28 days)
- alanine transaminase concentration after 14days oral Zn.(14days，28 days)
- albumin concentration after 14days oral Zn.(14days，28 days)
- total cholesterol concentration after 14days oral Zn.(14days，28 days)
- Urea concentration after 14days oral Zn.(14days，28 days)
- HDL-C concentration after 14days oral Zn.(14days，28 days)
- LDL-C concentration after 14days oral Zn.(14days，28 days)
- Red blood cells analysis after 14days oral Zn.(14days，28 days)
- Plateltes analysis after 14days oral Zn.(14days，28 days)
- Neutrophil cells analysis after 14days oral Zn.(14days，28 days)
- Eosinophil cells analysis after 14days oral Zn.(14days，28 days)
- Basophil cells analysis after 14days oral Zn.(14days，28 days)
- Lymphocyte cells analysis after 14days oral Zn.(14days，28 days)
- Monocyte cells analysis after 14days oral Zn.(14days，28 days)
- White blood cells analysis after 14days oral Zn.(14days，28 days)
Investigators
Yu Chen
chief physician
The Seventh Affiliated Hospital, Southern Medical University