Elevated Blood GlucoseNCT06807996
Effects of Zinc Supplementation on Patients With Elevated Glycemic Status
A study testing Zinc-enriched yeast capsule in people with Elevated Blood Glucose, run by Zhilei Shan.
Trial summary
The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Blood Glucose
- What is being tested?
- Zinc-enriched yeast capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting blood glucose ≥ 6.1 mmol /L;
- HBA1c ≥ 5.7%;
- OGTT 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;
- Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.
Who cannot join
- Age < 18 years, or currently pregnant;
- Individuals with severe obesity, thyroid disease, cardiovascular or cerebrovascular diseases, or other serious health conditions;
- Individuals with a previous diagnosis of type 2 diabetes currently receiving insulin therapy;
- Individuals who have taken zinc-related supplements within three months prior to baseline inclusion;
- Individuals using other nutritional supplements or with poor lifestyle habits;
- Individuals with unstable body weight in the past three months (fluctuations > 5 kg);
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- Individuals with a history of major surgery within the past three months or planned major surgery within the next month;
- Individuals allergic to the intervention materials;
- Individuals who did not adhere to the prescribed consumption of the study product, affecting efficacy or safety assessment;
- Individuals with positive urinary protein or serum creatinine greater than 1.2 times the upper limit of normal (men: serum creatinine > 133.2 μmol/L, women: serum creatinine > 97.2 μmol/L) at screening;
- Individuals with elevated alanine aminotransferase (ALT) levels at screening (men: ALT > 50 U/L, women: ALT > 35 U/L).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Zinc Supplementation on Patients With Elevated Glycemic Status: A Randomized Double-blind Placebo-controlled Clinical Trial
The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.
Read the detailed description
The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.
About 124 patients aged 18 years or older, had resided locally for at least one year, with elevated glycemic status will be enrolled in the study. Patients with elevated glycemic status are defined as meeting any of the following criteria:
- Fasting blood glucose ≥ 6.1 mmol/L;
- Glycated hemoglobin (HbA1c) ≥ 5.7%;
- Oral glucose tolerance test (OGTT) 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;
- Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.
Eligible participants will be assigned by chance to one of two groups: (1) daily zinc supplementation: zinc-enriched yeast capsules (4 mg); (2) daily edible yeast placebo capsules (not zinc-enriched) (4mg). Randomization will be conducted.
At enrollment, baseline questionnaires are designed to collect data on sociodemographic factors, lifestyle habits, health status, and medical conditions. Participants in both groups will take one capsule that contained either Zinc-enriched yeast or edible yeast placebo each day until the end of the intervention period.
Participants will be followed up two times (3 months and 6 months post-intervention), and receive a single stage-specific dosage at any given follow-up time. During each follow-up visit, participants will complete a questionnaire survey, a 3-day 24-hour dietary recall, and undergo physical measurements. Blood, urine, and stool samples will also be obtained in the study center, fasting blood glucose, HbA1c and other biochemical indicators will also be detected at the same time.
The primary outcomes, including fasting blood glucose and HbA1c will be measured using blood samples. Secondary outcomes in this study include changes in blood lipids (such as total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), trends in plasma zinc levels, inflammatory factors, oxidative stress indexes, other blood indicators and liver and kidney function indicators. Data will be collected and analyzed.
- Conditions
- Elevated Blood Glucose
- Being tested
- Zinc-enriched yeast capsule, Edible yeast placebo capsule
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc-enriched yeast capsuleDietary supplement
Daily zinc supplementation: zinc-enriched yeast capsules (15 mg) for a total of 6 months.
Edible yeast placebo capsuleDietary supplement
Daily edible yeast placebo capsules (not zinc-enriched) (15 mg) for a total of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Zinc supplementation | Experimental | zinc-enriched yeast capsule, 15mg/d Receives: Dietary Supplement: Zinc-enriched yeast capsule |
| Edible yeast placebo | Placebo comparator | Edible yeast placebo capsule, 15mg/d Receives: Dietary Supplement: Edible yeast placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of fasting blood glucose (FBG)
Concentration of FBG, measured in mmol/L
Measured: 0 week, 12th week, and 24th week in the intervention period
Glycated hemoglobin (HbA1c)
Concentration of HbA1c, measured in the percentage of hemoglobin
Measured: 0 week, 12th week, and 24th week in the intervention period
Secondary outcomes (14)
Concentration of fasting plasma insulin (FPI)
Concentration of FPI, measured in μIU/mL
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of plasma c-peptide
Concentration of plasma c-peptide, measured in nmol/L
Measured: 0 week, 12th week, and 24th week in the intervention period
Homeostatic model assessment of insulin resistance (HOMA-IR)
HOMA-IR can be calculated as (FPI [μU/mL] × FBG [mmol/L]) / 22.5
Measured: 0 week, 12th week, and 24th week in the intervention period
Homeostatic model assessment of β-cell function (HOMA-β)
HOMA-β is calculated as (20 × FPI [μU/mL]) / (FBG [mmol/L] - 0.195)
Measured: 0 week, 12th week, and 24th week in the intervention period
Homeostatic model assessment of insulin sensitivity (HOMA-S)
HOMA-S is calculated as 1 / HOMA-IR
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of blood lipids
Concentration of blood lipids: total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, measured in mmol/L
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of C-reactive protein (CRP)
Concentration of CRP, measured in mg/dL
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of interleukin-6 (IL-6)
Concentration of IL-6, measured in pg/mL
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of malondialdehyde (MDA)
Concentration of MDA, measured in μmol/L
Measured: 0 week, 12th week, and 24th week in the intervention period
Activity of Cu-Zn superoxide dismutase (SOD)
Activity of Cu-Zn SOD, measured in U/mL
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of homocysteine (HCY)
Homocysteine (HCY) [μmol/L]
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of plasma albumin (ALB)
Concentration of ALB, measured in g/dL
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of plasma creatinine
Concentration of plasma creatinine, measured in μmol/L
Measured: 0 week, 12th week, and 24th week in the intervention period
Concentration of plasma zinc
Concentration of plasma zinc concentrations, measured in mg/dL
Measured: 0 week, 12th week, and 24th week in the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhilei Shan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhilei Shan, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807996
- Sponsor's protocol ID
- S235
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Zinc Supplementation on Patients With Elevated Glycemic Status: A Randomized Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06807996
- Acronym / sponsor ID
- S235
- Conditions
- Elevated Blood Glucose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Zhilei ShanUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.
Detailed description
The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.
About 124 patients aged 18 years or older, had resided locally for at least one year, with elevated glycemic status will be enrolled in the study. Patients with elevated glycemic status are defined as meeting any of the following criteria:
- Fasting blood glucose ≥ 6.1 mmol/L;
- Glycated hemoglobin (HbA1c) ≥ 5.7%;
- Oral glucose tolerance test (OGTT) 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;
- Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.
Eligible participants will be assigned by chance to one of two groups: (1) daily zinc supplementation: zinc-enriched yeast capsules (4 mg); (2) daily edible yeast placebo capsules (not zinc-enriched) (4mg). Randomization will be conducted.
At enrollment, baseline questionnaires are designed to collect data on sociodemographic factors, lifestyle habits, health status, and medical conditions. Participants in both groups will take one capsule that contained either Zinc-enriched yeast or edible yeast placebo each day until the end of the intervention period.
Participants will be followed up two times (3 months and 6 months post-intervention), and receive a single stage-specific dosage at any given follow-up time. During each follow-up visit, participants will complete a questionnaire survey, a 3-day 24-hour dietary recall, and undergo physical measurements. Blood, urine, and stool samples will also be obtained in the study center, fasting blood glucose, HbA1c and other biochemical indicators will also be detected at the same time.
The primary outcomes, including fasting blood glucose and HbA1c will be measured using blood samples. Secondary outcomes in this study include changes in blood lipids (such as total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), trends in plasma zinc levels, inflammatory factors, oxidative stress indexes, other blood indicators and liver and kidney function indicators. Data will be collected and analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc supplementation | Experimental | Dietary Supplement: Zinc-enriched yeast capsulezinc-enriched yeast capsule, 15mg/d |
| Edible yeast placebo | Placebo comparator | Dietary Supplement: Edible yeast placebo capsuleEdible yeast placebo capsule, 15mg/d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fasting blood glucose ≥ 6.1 mmol /L;
- HBA1c ≥ 5.7%;
- OGTT 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;
- Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.
Key exclusion criteria (11 listed)
- Age < 18 years, or currently pregnant;
- Individuals with severe obesity, thyroid disease, cardiovascular or cerebrovascular diseases, or other serious health conditions;
- Individuals with a previous diagnosis of type 2 diabetes currently receiving insulin therapy;
- Individuals who have taken zinc-related supplements within three months prior to baseline inclusion;
- Individuals using other nutritional supplements or with poor lifestyle habits;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc-enriched yeast capsuleDaily zinc supplementation: zinc-enriched yeast capsules (15 mg) for a total of 6 months. | Dietary supplement | Zinc supplementation |
| Edible yeast placebo capsuleDaily edible yeast placebo capsules (not zinc-enriched) (15 mg) for a total of 6 months. | Dietary supplement | Edible yeast placebo |
Primary outcome
Concentration of fasting blood glucose (FBG)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of FBG, measured in mmol/L
Glycated hemoglobin (HbA1c)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of HbA1c, measured in the percentage of hemoglobin
14 secondary outcomes
Concentration of fasting plasma insulin (FPI)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of plasma c-peptide
Time frame: 0 week, 12th week, and 24th week in the intervention period
Homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Homeostatic model assessment of β-cell function (HOMA-β)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Homeostatic model assessment of insulin sensitivity (HOMA-S)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of blood lipids
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of C-reactive protein (CRP)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of interleukin-6 (IL-6)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of malondialdehyde (MDA)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Activity of Cu-Zn superoxide dismutase (SOD)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of homocysteine (HCY)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of plasma albumin (ALB)
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of plasma creatinine
Time frame: 0 week, 12th week, and 24th week in the intervention period
Concentration of plasma zinc
Time frame: 0 week, 12th week, and 24th week in the intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc-enriched yeast capsule in people with Elevated Blood Glucose, run by Zhilei Shan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhilei Shan, PHD (15871720906, zhileishan@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of fasting blood glucose (FBG) (time frame: 0 week, 12th week, and 24th week in the intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.