Trials Sponsors Conditions Drugs Pricing

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
+9 more secondary outcomes

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 capsuleDietary supplement

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

Zinc supplementation

Edible yeast placebo capsuleDietary supplement

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

Edible yeast placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Fasting blood glucose ≥ 6.1 mmol /L;
HBA1c ≥ 5.7%;

Sponsors & Collaborators

Zhilei Shan
Otherlead

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Zhilei Shan, PHD

CONTACT

15871720906 zhileishan@hust.edu.cn

Hongkun Di, BM

CONTACT

15931891138

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Effects of Zinc Supplementation on Patients With Elevated Glycemic Status

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (14)

Study Arms (2)

Zinc supplementation

Edible yeast placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (14)

Study Arms (2)

Zinc supplementation

Edible yeast placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record