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

November 4, 2024 updated by: Prof Rina Agustina, MD, PhD, Indonesia University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
670

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

31 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
A combination of Zinc, Chromium, Vitamin C, and Copper (ZCC supplement) with standard healthy lifestyle intervention
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.
Placebo Comparator: Control group
Placebo with standard healthy lifestyle intervention
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Fasting Blood Glucose (FBG)
Time Frame: 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
Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change of Hemoglobin A1c (HbA1c)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Delay Onset of Type 2 Diabetes Mellitus (T2DM) Progression
Time Frame: 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
Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change the Risk of T2DM Progression
Time Frame: 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
Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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))
Time Frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
To investigate the effect of ZCC supplementation among prediabetes adults on lipid profile (HDL, LDL, TG and total cholesterol)
Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change in Body Weight (kilogram)
Time Frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
To investigate the effect of ZCC supplementation among prediabetes adults on changing in body weight.
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)
Time Frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
To investigate the effect of ZCC supplementation among prediabetes adults on changing in BMI.
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)
Time Frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
To investigate the effect of ZCC supplementation among prediabetes adults on changing in 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
Time Frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
To determine the differences in changes of dietary intake after receiving 12 months of ZCC or placebo supplementation with standard healthy lifestyle intervention.
Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
The Difference of Zinc Level among prediabetes adults
Time Frame: Baseline (at the beginning of study)
To determine the difference of Zinc level in prediabetes adults.
Baseline (at the beginning of study)
The Difference of Chromium Level among prediabetes adults
Time Frame: Baseline (at the beginning of study)
To determine the difference of Chromium level in prediabetes adults.
Baseline (at the beginning of study)
Change in Physical Activity (assessed by IPAQ Questionnaire)
Time Frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
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.
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
Time Frame: Baseline (at the beginning of study) and 12 months (end of the study)
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.
Baseline (at the beginning of study) and 12 months (end of the study)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost Effectiveness Analysis of ZCC Supplement using Incremental cost-effectiveness ratio (ICER)
Time Frame: through study completion, an average of 1 year
Analyzing the cost effectiveness of intervention on Prediabetic adults comparing 2 different intervention models using incremental cost-effectiveness ratio (ICER). ICER is the ratio of the change in costs of a therapeutic intervention (compared to the alternative, such as doing nothing or using the best available alternative treatment) to the change in effects of the intervention.
through study completion, an average of 1 year
Change of Quality of Life Questionnaire (assessed by SF-36 questionnaire)
Time Frame: through study completion, an average of 1 year
To determine the quality of life of prediabetes adults using standardized questionnaire on control and intervention group. he range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
through study completion, an average of 1 year
Change in High-sensitivity C-Reactive Protein (hs-CRP) level (optional)
Time Frame: through study completion, an average of 2 year
To determine the difference of hs-CRP level in prediabetes adults with ZCC and placebo supplementation (optional).
through study completion, an average of 2 year
Change in Tumor Necrosis Factor-alpha (TNF-alpha) Level (optional)
Time Frame: through study completion, an average of 2 year
To determine the difference of TNF-alpha level in prediabetes adults with ZCC and placebo supplementation (optional).
through study completion, an average of 2 year
Change in Vitamin C Level (optional)
Time Frame: through study completion, an average of 2 year
To determine the difference of Vitamin C level in prediabetes adults with ZCC and placebo supplementation (optional).
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Blackmores Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rina Agustina, MD, MSc, PhD, HNRC-IMERI, Faculty of Medicine Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHANGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

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