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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
670
Combination of mineral and vitamin supplementation that consist of Zinc, Chromium, Vitamin C, and Copper
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.
Placebo with inactive ingredients
Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Change of Fasting Blood Glucose (FBG)
To investigate the effect of ZCC supplementation with standard healthy lifestyle intervention in improving Fasting Blood Glucose compared to placebo with standard healthy lifestyle intervention
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change of Hemoglobin A1c (HbA1c)
To investigate the effect of ZCC supplementation with standard healthy lifestyle intervention in improving HbA1c compared to placebo with standard healthy lifestyle intervention
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change of 2 hour Oral Glucose Tolerance Test (2-hour OGTT)
To investigate the effect of ZCC supplementation with standard healthy lifestyle intervention in improving 2 hour OGTT compared to placebo with standard healthy lifestyle intervention
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
To investigate the effect of ZCC supplementation with standard healthy lifestyle intervention in improving HOMA-IR compared to placebo with standard healthy lifestyle intervention
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Delay Onset of Type 2 Diabetes Mellitus (T2DM) Progression
Total participants who develop T2DM during study intervention as assessed by blood glucose
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change the Risk of T2DM Progression
Total participants whose blood glucose returned to normal during study intervention as assessed by blood glucose
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change in Lipid Profile (will be assessed by High Density Lipoprotein (HDL) in mg/dL, Low Density Lipoprotein (LDL) in mg/dL, Triglyceride (TG) in mg/dL, and total cholesterol in mg/dL))
To investigate the effect of ZCC supplementation among prediabetes adults on lipid profile (HDL, LDL, TG and total cholesterol)
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change in Body Weight (kilogram)
To investigate the effect of ZCC supplementation among prediabetes adults on changing in body weight.
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change in Body Mass Index (BMI) (weight and height will be combined to report the BMI in kg/m^2)
To investigate the effect of ZCC supplementation among prediabetes adults on changing in BMI.
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change in Percentage of Fat Mass (using Body Impedance Analysis)
To investigate the effect of ZCC supplementation among prediabetes adults on changing in fat mass using Body Impedance Analysis.
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change in Dietary intake
To determine the differences in changes of dietary intake after receiving 12 months of ZCC or placebo supplementation with standard healthy lifestyle intervention.
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
The Difference of Zinc Level among prediabetes adults
To determine the difference of Zinc level in prediabetes adults.
Time frame: Baseline (at the beginning of study)
The Difference of Chromium Level among prediabetes adults
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To determine the difference of Chromium level in prediabetes adults.
Time frame: Baseline (at the beginning of study)
Change in Physical Activity (assessed by IPAQ Questionnaire)
To determine the difference of physical activity in prediabetes adults using standardized questionnaire on control and intervention group. Moderate intensity activities have been established as between 3 and 6 METS (metabolic equivalent of task). One MET is the amount of energy used while sitting quietly. Physical activities will be rated using METs to indicate their intensity. Vigorous-intensity activity activities have been established as \>6 METs. The higher the MET scores mean a better physical activity.
Time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
The assessment on the Safety of the ZCC Supplementation for the respondents
To investigate the safety of the ZCC supplementation among prediabetes adults on the kidney function, liver function, and complete peripheral blood to assess whether the supplements have the specific effects for the respondents' organ function.
Time frame: Baseline (at the beginning of study) and 12 months (end of the study)