Effects of Zinc Supplementation on Patients With Elevated Glycemic Status

NCT06807996 | Not Yet Recruiting

• 1 other identifier: S235
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elevated Blood Glucose

Outcome Measures

Primary Outcomes (2)

• Concentration of fasting blood glucose (FBG)

  Concentration of FBG, measured in mmol/L

  0 week, 12th week, and 24th week in the intervention period

• Glycated hemoglobin (HbA1c)

  Concentration of HbA1c, measured in the percentage of hemoglobin

  0 week, 12th week, and 24th week in the intervention period

Secondary Outcomes (14)

• Concentration of fasting plasma insulin (FPI)

  0 week, 12th week, and 24th week in the intervention period

• Concentration of plasma c-peptide

  0 week, 12th week, and 24th week in the intervention period

• Homeostatic model assessment of insulin resistance (HOMA-IR)

  0 week, 12th week, and 24th week in the intervention period

• Homeostatic model assessment of β-cell function (HOMA-β)

  0 week, 12th week, and 24th week in the intervention period

• Homeostatic model assessment of insulin sensitivity (HOMA-S)

  0 week, 12th week, and 24th week in the intervention period

Study Arms (2)

Zinc supplementation

EXPERIMENTAL

zinc-enriched yeast capsule, 15mg/d

Dietary Supplement: Zinc-enriched yeast capsule

Edible yeast placebo

PLACEBO COMPARATOR

Edible yeast placebo capsule, 15mg/d

Dietary Supplement: Edible yeast placebo capsule

Interventions

Zinc-enriched yeast capsule DIETARY_SUPPLEMENT

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

Zinc supplementation

Edible yeast placebo capsule DIETARY_SUPPLEMENT

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

Edible yeast placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 using other nutritional supplements or with poor lifestyle habits;
• Individuals with unstable body weight in the past three months (fluctuations \> 5 kg);
• 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).

Sponsors & Collaborators

• Zhilei Shan: lead

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Zhilei Shan, PHD

CONTACT

15871720906; zhileishan@hust.edu.cn

Hongkun Di, BM

CONTACT

15931891138; hongkundi2020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share