Zinc Chromium Vitamin C and Copper Combination Supplement for Prediabetes Progression

  • STATUS
    Recruiting
  • End date
    Mar 21, 2024
  • participants needed
    670
  • sponsor
    Indonesia University
Updated on 31 August 2021
insulin
fasting
oral glucose tolerance test
insulin resistance
fasting blood glucose
hemoglobin a1c
glucose tolerance test
plasma glucose

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.

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).
  5. Exploratory Objectives:
  6. To determine cost effectiveness of intervention on prediabetic adults comparing two different intervention models
  7. To determine the quality of life of prediabetes adults receiving a combination of zinc, chromium, vitamin C, and copper supplementation.
  8. 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.

Details
Condition pre-diabetic, Nutritional status, Diabetes (Pediatric), Prediabetes, Diabetes Mellitus, prediabetic state, Diabetes Mellitus Types I and II, nutritional science, Diabetes Prevention, Glucose Intolerance
Treatment Placebo, Zinc, Chromium, Vitamin C, and Copper Supplementation, Standard healthy lifestyle intervention
Clinical Study IdentifierNCT04511468
SponsorIndonesia University
Last Modified on31 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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