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

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ClinicalTrials.gov Identifier: NCT04511468
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : August 24, 2021
Sponsor:
Collaborator:
Blackmores Institute
Information provided by (Responsible Party):
Rina Agustina, Indonesia University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
PreDiabetes Nutrition Dietary Supplement: Zinc, Chromium, Vitamin C, and Copper Supplementation Behavioral: Standard healthy lifestyle intervention Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

There will be two arms of intervention:

Arm 1: A combination of Zinc, Chromium, Vitamin C, and Copper (ZCC supplement) with standard healthy lifestyle intervention.

Arm 2: A combination of placebo with standard healthy lifestyle intervention.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Independent party will mask the product.
Primary Purpose: Prevention
Official Title: A Combination of Zinc, Chromium, Vitamin C, and Copper Supplement for Prediabetes Progression: Randomized Controlled-Trial in Jakarta
Actual Study Start Date : June 23, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 21, 2024


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511468


Contacts
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Contact: Rina Agustina, MD, MSc, PhD +62 21 3912477 r.agustina@ui.ac.id; dr.rinaagustina@gmail.com
Contact: Hanifa Hanifa, Master +62 21 3912477 hnrc.imeri@gmail.com

Locations
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Indonesia
Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Rina Agustina, PhD    +62-21-3912477    r.agustina@ui.ac.id   
Contact: Hanifa Hanifa, MBiomed    +62-21-3912477    hnrc.imeri@gmail.com   
Principal Investigator: Rina Agustina, MD, MSc, PhD         
Sub-Investigator: Erfi Prafiantini, MD, MKes         
Sub-Investigator: Hanifa Hanifa, MBiomed         
Sub-Investigator: Pradana Soewondo, MD, Prof         
Sub-Investigator: Anuraj H Shankar, DSc         
Sponsors and Collaborators
Indonesia University
Blackmores Institute
Investigators
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Principal Investigator: Rina Agustina, MD, MSc, PhD HNRC-IMERI, Faculty of Medicine Universitas Indonesia
Publications:

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Responsible Party: Rina Agustina, dr. Rina Agustina, M.Sc., PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT04511468    
Other Study ID Numbers: CHANGE
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rina Agustina, Indonesia University:
Zinc
Chromium
Copper
Vitamin C
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Ascorbic Acid
Copper
Chromium
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements