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ACTIVE NOT RECRUITING
NCT04511468
PHASE2

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

Sponsor: Indonesia University

View on ClinicalTrials.gov

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.

Official title: A Combination of Zinc, Chromium, Vitamin C, and Copper Supplement for Prediabetes Progression: Randomized Controlled-Trial in Jakarta

Key Details

Gender

All

Age Range

35 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

670

Start Date

2021-06-23

Completion Date

2025-03-31

Last Updated

2024-11-05

Healthy Volunteers

Yes

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

Locations (1)

Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia