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Completed

NCT Number: NCT05597137

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

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.

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Key information

Conditions

Healthy

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern Medical Unversity，the seventh affiliated hospital

Foshan, Guangdong, 528000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zinc gluconate

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. metabolomic analysis of serum and feces

    Time frame: 14days，28 days

    To determine the alteration of gut microbiota after Zn supplementary.

  3. 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.

  4. 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

  5. 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.

Secondary outcomes

  1. Total bilirubin concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in Total bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.

  2. Direct bilirubin concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in Direct bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.

  3. Indirect bilirubin concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in indirect bilirubin and analyzed by the AU5800 fully automatic biochemical analyzer.

  4. uric acid concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in uric acid and analyzed by the AU5800 fully automatic biochemical analyzer.

  5. total triglyceride concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in total triglyceride and analyzed by the AU5800 fully automatic biochemical analyzer.

  6. total protein concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in total protein and analyzed by the AU5800 fully automatic biochemical analyzer.

  7. aspartate transaminase concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in aspartate transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.

  8. alanine transaminase concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in alanine transaminase and analyzed by the AU5800 fully automatic biochemical analyzer.

  9. albumin concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in albumin and analyzed by the AU5800 fully automatic biochemical analyzer.

  10. total cholesterol concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in total cholesterol and analyzed by the AU5800 fully automatic biochemical analyzer.

  11. Urea concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14 days in urea and analyzed by the AU5800 fully automatic biochemical analyzer.

  12. HDL-C concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14 days in HDL-C(high density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic

  13. LDL-C concentration after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14 days in LDC-C(low density lipoprotein cholesterol) and analyzed by the AU5800 fully automatic

  14. Red blood cells analysis after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in Red blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  15. Plateltes analysis after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14 days in Plateltes and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  16. Neutrophil cells analysis after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in Neutrophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  17. Eosinophil cells analysis after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14days in Eosinophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  18. Basophil cells analysis after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14 days in Basophil cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  19. Lymphocyte cells analysis after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14 days in Lymphocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  20. Monocyte cells analysis after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14 days in Monocyte cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

  21. White blood cells analysis after 14days oral Zn.

    Time frame: 14days，28 days

    change from 14 days in white blood cells and determined by a Sysmex-xn-2000 automatic blood cell analyser.

Sponsors and collaborators

Lead sponsor

The Seventh Affiliated Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2022
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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