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

University of Indonesia (UI)

Status and phase: Active, not recruiting; Phase 2

Conditions: Nutrition; PreDiabetes

Treatments: Other: Placebo; Behavioral: Standard healthy lifestyle intervention; Dietary Supplement: Zinc, Chromium, Vitamin C, and Copper Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT04511468

CHANGE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 670 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

670 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

A combination of Zinc, Chromium, Vitamin C, and Copper (ZCC supplement) with standard healthy lifestyle intervention

Treatment:

Dietary Supplement: Zinc, Chromium, Vitamin C, and Copper Supplementation

Behavioral: Standard healthy lifestyle intervention

Control group

Placebo Comparator group

Description:

Placebo with standard healthy lifestyle intervention

Treatment:

Behavioral: Standard healthy lifestyle intervention

Other: Placebo