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

NCT04511468 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CHANGE
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Nutrition

Keywords

Zinc; Chromium; Copper; Vitamin C

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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

  Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months

Secondary Outcomes (9)

• 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 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 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

Other Outcomes (5)

• Cost Effectiveness Analysis of ZCC Supplement using Incremental cost-effectiveness ratio (ICER)

  through study completion, an average of 1 year

• Change of Quality of Life Questionnaire (assessed by SF-36 questionnaire)

  through study completion, an average of 1 year

• Change in High-sensitivity C-Reactive Protein (hs-CRP) level (optional)

  through study completion, an average of 2 year

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; Behavioral: Standard healthy lifestyle intervention

Control group

PLACEBO COMPARATOR

Placebo with standard healthy lifestyle intervention

Behavioral: Standard healthy lifestyle intervention; Other: Placebo

Interventions

Zinc, Chromium, Vitamin C, and Copper Supplementation DIETARY_SUPPLEMENT

Combination of mineral and vitamin supplementation that consist of Zinc, Chromium, Vitamin C, and Copper

Experimental Group

Standard healthy lifestyle intervention BEHAVIORAL

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.

Control group; Experimental Group

Placebo OTHER

Placebo with inactive ingredients

Control group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Blackmores Institute: collaborator

Study Sites (1)

Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (21)

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  PMID: 40653308 DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Zinc; Chromium; Ascorbic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Rina Agustina, MD, MSc, PhD

  HNRC-IMERI, Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Independent party will mask the product.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Rina Agustina, M.Sc., PhD

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: August 13, 2020
• Study Start: June 23, 2021
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)