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

Summary

Participation Requirements

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...

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. Primary Objective: To investigate the effect of a combination of Zinc, Chromium, Vitamin C, and Copper supplementation (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 (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 counseling. Secondary Objectives: To investigate the effect of a combination of Zinc, Chromium, Vitamin C, and Copper supplementation (ZCC supplementation) among prediabetic adults compared to the placebo supplementation on: Lipid profile [Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), Triglyceride]; Hemoglobin A1c (HbA1c); Body weight and composition (body weight, Body Mass Index (BMI), visceral fat). Exploratory Objectives: To determine cost effectiveness of intervention on prediabetic adults comparing two different intervention models; To determine the quality of life of prediabetes adults receiving a combination of zinc, chromium, vitamin C, and copper supplementation; To determine the difference of dietary intake and physical activity in prediabetes adults with ZCC and placebo supplementation; Level of High-sensitivity C-reactive Protein (hs-CRP); Tumor Necrosis Factor-alpha (TNF-alpha), Zinc, Chromium, and Vitamin C will be assessed later if needed (optional) Study Design: This study is a double-blind, randomized, placebo-controlled trial in 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.

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