Clinical Trial

Zinc, Chromium, Vitamin C, and Copper Combination Supplement for Prediabetes Progression

Study acronym: CHANGE
Active, Not Recruiting Phase 2
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Record status
This record was last updated November 5, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
Summary
Currently, the incidence of diabetes mellitus is increasing worldwide. People with prediabetes have higher risk to develop diabetes mellitus type 2. Several studies have proven that Zinc and Chromium are minerals that contribute to decreasing the level of blood glucose and insulin resistance. In addition, vitamin C also contributes in decreasing Fasting Blood Glucose (FBG) and Hemoglobin A1c (HbA1c). However, the eficacy of a combined zinc, chromium, vitamin C, and copper (ZCC) in decreasing blood glucose in prediabetic people has never been performed. The primary objective of this study is to investigate the effect of a combination of ZCC supplementation with standard healthy lifestyle counseling in improving glucose profile \[Fasting Blood Glucose (FBG), 2-hour Oral Glucose Tolerance Test (OGTT), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)\] from prediabetes to normal or reducing the risk of progression from prediabetes to Type 2-Diabetes Mellitus (T2DM) compared to placebo with standard healthy lifestyle intervention.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-08-10; most recent amendment 2024-11-04.
Status change: Recruiting → Active, Not Recruiting 2024-11-04
Status change: Not Yet Recruiting → Recruiting 2021-08-20
Trial Details
NCT Number NCT04511468
Lead Sponsor Indonesia University
Collaborators: Blackmores Institute
Conditions PreDiabetes, Nutrition
Enrollment 670 participants
Start Date 2021-06-23
Primary Completion 2024-12-31 (estimated)
Study Completion 2025-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-05