NCT04511468

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 670 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Diabetes is an important public health problem as the number of people with diabetes are increasing across the world and contributes to high mortality burden. Prediabetes is an intermediate stage between normal glucose tolerance and type 2 diabetes mellitus. Furthermore, people with prediabetes have higher risk to develop diabetes mellitus type 2. There are several objectives in this study, such as primary objective, secondary objectives, and exploratory objectives. 1. Primary Objective: To investigate the effect of a combination of Zinc, Chromium, Vitamin C, and Copper supplementation (ZCC supplementation) with standard healthy lifestyle intervention 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 (reducing the proportion of prediabetes and increasing the proportion to become normal) or reducing the risk of progression from prediabetes to Type 2-Diabetes Mellitus (T2DM) compared to placebo with standard healthy lifestyle intervention. 2. Secondary Objectives: To investigate the level of Zinc and Chromium among the prediabetes, the safety of the ZCC supplementation, and the effect of a combination of Zinc, Chromium, Vitamin C, and Copper supplementation (ZCC supplementation) among prediabetic adults compared to the placebo supplementation on: 1. Lipid profile \[Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), Triglyceride\]; 2. Hemoglobin A1c (HbA1c); 3. Dietary intake and physical activity 4. Body weight and composition (body weight, Body Mass Index (BMI), body fat). 3. Exploratory Objectives: 1. To determine cost effectiveness of intervention on prediabetic adults comparing two different intervention models 2. To determine the quality of life of prediabetes adults receiving a combination of zinc, chromium, vitamin C, and copper supplementation. 3. Level of hs-crp; TNF-alpha and Vitamin C will be assessed later if needed (optional) Study Design: This study is a double-blind, randomized, placebo-controlled trial in the community setting, with two arms of intervention involving a total of 670 people. Study Duration: This study is a two-year study with 1 year of intervention for each subject.

Conditions

• PreDiabetes
• Nutrition

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-23
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2020-08-13
• Last updated: 2024-11-05

Locations

1 site across 1 country: Indonesia