A Combination of Zinc, Chromium, Vitamin C, and Copper Supplement for Prediabetes Progression: Randomized Controlled-Trial in Jakarta
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 670
- 试验地点
- 2
- 主要终点
- Change the Risk of T2DM Progression
研究概览
简要总结
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.
详细描述
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 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:
- Lipid profile [Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), Triglyceride];
- Hemoglobin A1c (HbA1c);
- Dietary intake and physical activity
- Body weight and composition (body weight, Body Mass Index (BMI), body fat).
- Exploratory Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Independent party will mask the product.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 35-65 years old;
- •Being prediabetes as assessed by having fasting plasma glucose (FPG) level in the range of 100 mg/dL to 125 mg/dL; having 2-h values in the oral glucose tolerance (OGTT) level in the range of 140 mg/dL to 199 mg/dL;
- •The study subjects will be recruited from household communities connected to any health care facilities such as primary health center, private clinics or private GP/specialist on the national health care system;
- •The subjects are willing to sign informed consent;
- •The subjects are willing to stay commitment during the study, at least 1 year;
- •Having app-android mobile
排除标准
- •Pregnancy or lactation women;
- •Transgender on hormonal injection;
- •Bariatric surgery;
- •Consuming other pills supplementation containing zinc and/or chromium, copper, vitamin C in regular basis;
- •History of Inflammatory Bowel Disease (IBD), psychiatric disorders, chronic diseases (e.g., HIV, Cushing syndrome, CKD, acromegaly, hyperthyroidism, etc.);
- •Not healthy (current status of the severely malnourished, acute problem of any severe disease, history of impaired hepatic, renal failure, heart failure, cancer, other catastrophic diseases.
- •Currently using weight loss medication;
- •Consuming pharmacology agents that might interfere the intervention (such as metformin, methylprednisolone, methyltestosterone, diuretics, complementary medicines);
- •Subjects who are unable to read and understand the statements of consent form
结局指标
主要结局
Change the Risk of T2DM Progression
时间窗: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Total participants whose blood glucose returned to normal during study intervention as assessed by blood glucose
Change of Fasting Blood Glucose (FBG)
时间窗: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
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
Change of Hemoglobin A1c (HbA1c)
时间窗: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
To investigate the effect of ZCC supplementation with standard healthy lifestyle intervention in improving HbA1c compared to placebo with standard healthy lifestyle intervention
Change of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
时间窗: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
To investigate the effect of ZCC supplementation with standard healthy lifestyle intervention in improving HOMA-IR compared to placebo with standard healthy lifestyle intervention
Change of 2 hour Oral Glucose Tolerance Test (2-hour OGTT)
时间窗: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
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
Delay Onset of Type 2 Diabetes Mellitus (T2DM) Progression
时间窗: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Total participants who develop T2DM during study intervention as assessed by blood glucose
次要结局
- Change in Body Weight (kilogram)(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)(Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months)
- Change in Physical Activity (assessed by IPAQ Questionnaire)(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(Baseline (at the beginning of study) and 12 months (end of the study))
- 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))(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)(Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months)
- Change in Dietary intake(Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months)
- The Difference of Chromium Level among prediabetes adults(Baseline (at the beginning of study))
- The Difference of Zinc Level among prediabetes adults(Baseline (at the beginning of study))
研究者
Prof Rina Agustina, MD, PhD
dr. Rina Agustina, M.Sc., PhD
Indonesia University