Effects of Zinc Supplementation on Patients With Elevated Glycemic Status

NCT ID: NCT06807996

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-01

Brief 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.

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:

1. Fasting blood glucose ≥ 6.1 mmol/L;

2. Glycated hemoglobin (HbA1c) ≥ 5.7%;

3. Oral glucose tolerance test (OGTT) 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Zinc supplementation

zinc-enriched yeast capsule, 15mg/d

Group Type: EXPERIMENTAL

Zinc-enriched yeast capsule

Intervention Type: DIETARY_SUPPLEMENT

Daily zinc supplementation: zinc-enriched yeast capsules (15 mg) for a total of 6 months.

Edible yeast placebo

Edible yeast placebo capsule, 15mg/d

Group Type: PLACEBO_COMPARATOR

Edible yeast placebo capsule

Intervention Type: DIETARY_SUPPLEMENT

Daily edible yeast placebo capsules (not zinc-enriched) (15 mg) for a total of 6 months.

Interventions

Zinc-enriched yeast capsule

Daily zinc supplementation: zinc-enriched yeast capsules (15 mg) for a total of 6 months.

Intervention Type: DIETARY_SUPPLEMENT

Edible yeast placebo capsule

Daily edible yeast placebo capsules (not zinc-enriched) (15 mg) for a total of 6 months.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Fasting blood glucose ≥ 6.1 mmol /L;

2. HBA1c ≥ 5.7%;

3. OGTT 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;

4. Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.

Exclusion Criteria

1. Age < 18 years, or currently pregnant;

2. Individuals with severe obesity, thyroid disease, cardiovascular or cerebrovascular diseases, or other serious health conditions;

3. Individuals with a previous diagnosis of type 2 diabetes currently receiving insulin therapy;

4. Individuals who have taken zinc-related supplements within three months prior to baseline inclusion;

5. Individuals using other nutritional supplements or with poor lifestyle habits;

6. Individuals with unstable body weight in the past three months (fluctuations > 5 kg);

7. Individuals with a history of major surgery within the past three months or planned major surgery within the next month;

8. Individuals allergic to the intervention materials;

9. Individuals who did not adhere to the prescribed consumption of the study product, affecting efficacy or safety assessment;

10. 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;

11. Individuals with elevated alanine aminotransferase (ALT) levels at screening (men: ALT > 50 U/L, women: ALT > 35 U/L).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhilei Shan

OTHER

Sponsor Role: lead

Responsible Party

Zhilei Shan

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Zhilei Shan, PHD

Role: CONTACT

zhileishan@hust.edu.cn

15871720906

Hongkun Di, BM

Role: CONTACT

hongkundi2020@163.com

15931891138

Other Identifiers

S235

Identifier Type: -

Identifier Source: org_study_id