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

NCT04511468 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Zinc, Chromium, Vitamin C, and Copper Supplementation

Combination of mineral and vitamin supplementation that consist of Zinc, Chromium, Vitamin C, and Copper

BEHAVIORAL

Standard healthy lifestyle intervention

Standard healthy lifestyle intervention will follow the Guidelines on the Management and Prevention of Prediabetes by the Indonesian Ministry of Healthy and the Indonesian Diabetes Association.

OTHER

Placebo

Placebo with inactive ingredients

Sponsors & Collaborators

  • Blackmores Institute

    collaborator INDUSTRY

  • Indonesia University

    lead OTHER

Principal Investigators

  • Rina Agustina, MD, MSc, PhD · HNRC-IMERI, Faculty of Medicine Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04511468 on ClinicalTrials.gov