PreDiabetesPhase 2CHANGENCT04511468
Zinc, Chromium, Vitamin C, and Copper Combination Supplement for Prediabetes Progression
A Phase 2 study testing Zinc, Chromium, Vitamin C, and Copper Supplementation and Standard healthy lifestyle intervention in people with PreDiabetes and Nutrition, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Nutrition
- What is being tested?
- Zinc, Chromium, Vitamin C, and Copper Supplementation and Standard healthy lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 670 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Jun 2021to 31 Mar 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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.
Read the 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.
- 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.
- 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:
- Lipid profile [Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), Triglyceride];
- Hemoglobin A1c (HbA1c);
- Dietary intake and physical activity
- Body weight and composition (body weight, Body Mass Index (BMI), body fat).
- Exploratory Objectives:
- To determine cost effectiveness of intervention on prediabetic adults comparing two different intervention models
- To determine the quality of life of prediabetes adults receiving a combination of zinc, chromium, vitamin C, and copper supplementation.
- 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.
- Conditions
- PreDiabetes, Nutrition
- Being tested
- Zinc, Chromium, Vitamin C, and Copper Supplementation, Standard healthy lifestyle intervention, Placebo
- Keywords
- Zinc, Chromium, Copper, Vitamin C
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc, Chromium, Vitamin C, and Copper SupplementationDietary supplement
Combination of mineral and vitamin supplementation that consist of Zinc, Chromium, Vitamin C, and Copper
Standard healthy lifestyle interventionBehavioural
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.
PlaceboOther
Placebo with inactive ingredients
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | A combination of Zinc, Chromium, Vitamin C, and Copper (ZCC supplement) with standard healthy lifestyle intervention Receives: Dietary Supplement: Zinc, Chromium, Vitamin C, and Copper Supplementation; Behavioral: Standard healthy lifestyle intervention |
| Control group | Placebo comparator | Placebo with standard healthy lifestyle intervention Receives: Behavioral: Standard healthy lifestyle intervention; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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))
To investigate the effect of ZCC supplementation among prediabetes adults on lipid profile (HDL, LDL, TG and total cholesterol)
Measured: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change in Body Weight (kilogram)
To investigate the effect of ZCC supplementation among prediabetes adults on changing in body weight.
Measured: 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)
To investigate the effect of ZCC supplementation among prediabetes adults on changing in BMI.
Measured: 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)
To investigate the effect of ZCC supplementation among prediabetes adults on changing in fat mass using Body Impedance Analysis.
Measured: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
Change in Dietary intake
To determine the differences in changes of dietary intake after receiving 12 months of ZCC or placebo supplementation with standard healthy lifestyle intervention.
Measured: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months
The Difference of Zinc Level among prediabetes adults
To determine the difference of Zinc level in prediabetes adults.
Measured: Baseline (at the beginning of study)
The Difference of Chromium Level among prediabetes adults
To determine the difference of Chromium level in prediabetes adults.
Measured: Baseline (at the beginning of study)
Change in Physical Activity (assessed by IPAQ Questionnaire)
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.
Measured: 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
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.
Measured: Baseline (at the beginning of study) and 12 months (end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start23 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Blackmores Institute
- Responsible party
- Principal investigator, Prof Rina Agustina, MD, PhD, Universitas Indonesia
- Investigators
- Rina Agustina, MD, MSc, PhD, Principal investigator, HNRC-IMERI, Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511468
- Sponsor's protocol ID
- CHANGE
- Acronym
- CHANGE
- Status last verified
- Nov 2024
- First submitted
- 1 Jun 2020
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jayawardena R, Ranasinghe P, Byrne NM, Soares MJ, Katulanda P, Hills AP. Prevalence and trends of the diabetes epidemic in South Asia: a systematic review and meta-analysis. BMC Public Health. 2012 May 25;12:380. doi: 10.1186/1471-2458-12-380.
PubMed 22630043Jayawardena R, Ranasinghe P, Galappatthy P, Malkanthi R, Constantine G, Katulanda P. Effects of zinc supplementation on diabetes mellitus: a systematic review and meta-analysis. Diabetol Metab Syndr. 2012 Apr 19;4(1):13. doi: 10.1186/1758-5996-4-13.
PubMed 22515411Dall TM, Yang W, Gillespie K, Mocarski M, Byrne E, Cintina I, Beronja K, Semilla AP, Iacobucci W, Hogan PF. The Economic Burden of Elevated Blood Glucose Levels in 2017: Diagnosed and Undiagnosed Diabetes, Gestational Diabetes Mellitus, and Prediabetes. Diabetes Care. 2019 Sep;42(9):1661-1668. doi: 10.2337/dc18-1226. Epub 2019 Apr 2.
PubMed 30940641Janghorbani M, Amini M. Normal fasting plasma glucose and risk of prediabetes and type 2 diabetes: the Isfahan Diabetes Prevention Study. Rev Diabet Stud. 2011 Winter;8(4):490-8. doi: 10.1900/RDS.2011.8.490. Epub 2012 Feb 10.
PubMed 22580730Aroda VR, Ratner R. Approach to the patient with prediabetes. J Clin Endocrinol Metab. 2008 Sep;93(9):3259-65. doi: 10.1210/jc.2008-1091.
PubMed 18772457Kelly FJ. Use of antioxidants in the prevention and treatment of disease. J Int Fed Clin Chem. 1998 Mar;10(1):21-3.
PubMed 10181011Capdor J, Foster M, Petocz P, Samman S. Zinc and glycemic control: a meta-analysis of randomised placebo controlled supplementation trials in humans. J Trace Elem Med Biol. 2013 Apr;27(2):137-42. doi: 10.1016/j.jtemb.2012.08.001. Epub 2012 Nov 6.
PubMed 23137858Ranasinghe P, Wathurapatha WS, Galappatthy P, Katulanda P, Jayawardena R, Constantine GR. Zinc supplementation in prediabetes: A randomized double-blind placebo-controlled clinical trial. J Diabetes. 2018 May;10(5):386-397. doi: 10.1111/1753-0407.12621. Epub 2018 Jan 3.
PubMed 29072815Guo CH, Wang CL. Effects of zinc supplementation on plasma copper/zinc ratios, oxidative stress, and immunological status in hemodialysis patients. Int J Med Sci. 2013;10(1):79-89. doi: 10.7150/ijms.5291. Epub 2012 Dec 22.
PubMed 23289009Kim HN, Kim SH, Eun YM, Song SW. Effects of zinc, magnesium, and chromium supplementation on cardiometabolic risk in adults with metabolic syndrome: A double-blind, placebo-controlled randomised trial. J Trace Elem Med Biol. 2018 Jul;48:166-171. doi: 10.1016/j.jtemb.2018.03.022. Epub 2018 Mar 30.
PubMed 29773176Bartlett HE, Eperjesi F. Nutritional supplementation for type 2 diabetes: a systematic review. Ophthalmic Physiol Opt. 2008 Nov;28(6):503-23. doi: 10.1111/j.1475-1313.2008.00595.x.
PubMed 19076553Abdollahi M, Farshchi A, Nikfar S, Seyedifar M. Effect of chromium on glucose and lipid profiles in patients with type 2 diabetes; a meta-analysis review of randomized trials. J Pharm Pharm Sci. 2013;16(1):99-114. doi: 10.18433/j3g022.
PubMed 23683609Will JC, Ford ES, Bowman BA. Serum vitamin C concentrations and diabetes: findings from the Third National Health and Nutrition Examination Survey, 1988-1994. Am J Clin Nutr. 1999 Jul;70(1):49-52. doi: 10.1093/ajcn/70.1.49.
PubMed 10393138Eriksson J, Kohvakka A. Magnesium and ascorbic acid supplementation in diabetes mellitus. Ann Nutr Metab. 1995;39(4):217-23. doi: 10.1159/000177865.
PubMed 8546437Ashor AW, Werner AD, Lara J, Willis ND, Mathers JC, Siervo M. Effects of vitamin C supplementation on glycaemic control: a systematic review and meta-analysis of randomised controlled trials. Eur J Clin Nutr. 2017 Dec;71(12):1371-1380. doi: 10.1038/ejcn.2017.24. Epub 2017 Mar 15.
PubMed 28294172
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Zinc, Chromium, Vitamin C, and Copper Supplement for Prediabetes Progression: Randomized Controlled-Trial in Jakarta
- ClinicalTrials.gov ID
- NCT04511468
- Acronym / sponsor ID
- CHANGE / CHANGE
- Conditions
- PreDiabetes, Nutrition
- Keywords
- Zinc, Chromium, Copper, Vitamin C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Blackmores Institute
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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:
- Lipid profile [Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), Triglyceride];
- Hemoglobin A1c (HbA1c);
- Dietary intake and physical activity
- Body weight and composition (body weight, Body Mass Index (BMI), body fat).
- Exploratory Objectives:
- To determine cost effectiveness of intervention on prediabetic adults comparing two different intervention models
- To determine the quality of life of prediabetes adults receiving a combination of zinc, chromium, vitamin C, and copper supplementation.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Zinc, Chromium, Vitamin C, and Copper Supplementation, Behavioral: Standard healthy lifestyle interventionA combination of Zinc, Chromium, Vitamin C, and Copper (ZCC supplement) with standard healthy lifestyle intervention |
| Control group | Placebo comparator | Behavioral: Standard healthy lifestyle intervention, Other: PlaceboPlacebo with standard healthy lifestyle intervention |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc, Chromium, Vitamin C, and Copper SupplementationCombination of mineral and vitamin supplementation that consist of Zinc, Chromium, Vitamin C, and Copper | Dietary supplement | Experimental Group |
| Standard healthy lifestyle interventionStandard 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. | Behavioural | Control group, Experimental Group |
| PlaceboPlacebo with inactive ingredients | Other | Control group |
Primary outcome
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
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
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
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
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
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
9 secondary outcomes
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
Change in Body Weight (kilogram)
Time frame: 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
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
Change in Dietary intake
Time frame: 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)
The Difference of Chromium Level among prediabetes adults
Time frame: 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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 22630043Jayawardena R, Ranasinghe P, Byrne NM, Soares MJ, Katulanda P, Hills AP. Prevalence and trends of the diabetes epidemic in South Asia: a systematic review and meta-analysis. BMC Public Health. 2012 May 25;12:380. doi: 10.1186/1471-2458-12-380.
- Background: PubMed 22515411Jayawardena R, Ranasinghe P, Galappatthy P, Malkanthi R, Constantine G, Katulanda P. Effects of zinc supplementation on diabetes mellitus: a systematic review and meta-analysis. Diabetol Metab Syndr. 2012 Apr 19;4(1):13. doi: 10.1186/1758-5996-4-13.
- Background: PubMed 30940641Dall TM, Yang W, Gillespie K, Mocarski M, Byrne E, Cintina I, Beronja K, Semilla AP, Iacobucci W, Hogan PF. The Economic Burden of Elevated Blood Glucose Levels in 2017: Diagnosed and Undiagnosed Diabetes, Gestational Diabetes Mellitus, and Prediabetes. Diabetes Care. 2019 Sep;42(9):1661-1668. doi: 10.2337/dc18-1226. Epub 2019 Apr 2.
- Background: PubMed 22580730Janghorbani M, Amini M. Normal fasting plasma glucose and risk of prediabetes and type 2 diabetes: the Isfahan Diabetes Prevention Study. Rev Diabet Stud. 2011 Winter;8(4):490-8. doi: 10.1900/RDS.2011.8.490. Epub 2012 Feb 10.
- Background: PubMed 18772457Aroda VR, Ratner R. Approach to the patient with prediabetes. J Clin Endocrinol Metab. 2008 Sep;93(9):3259-65. doi: 10.1210/jc.2008-1091.
- Background: PubMed 10181011Kelly FJ. Use of antioxidants in the prevention and treatment of disease. J Int Fed Clin Chem. 1998 Mar;10(1):21-3.
- Background: PubMed 23137858Capdor J, Foster M, Petocz P, Samman S. Zinc and glycemic control: a meta-analysis of randomised placebo controlled supplementation trials in humans. J Trace Elem Med Biol. 2013 Apr;27(2):137-42. doi: 10.1016/j.jtemb.2012.08.001. Epub 2012 Nov 6.
- Background: PubMed 29072815Ranasinghe P, Wathurapatha WS, Galappatthy P, Katulanda P, Jayawardena R, Constantine GR. Zinc supplementation in prediabetes: A randomized double-blind placebo-controlled clinical trial. J Diabetes. 2018 May;10(5):386-397. doi: 10.1111/1753-0407.12621. Epub 2018 Jan 3.
- Background: PubMed 23289009Guo CH, Wang CL. Effects of zinc supplementation on plasma copper/zinc ratios, oxidative stress, and immunological status in hemodialysis patients. Int J Med Sci. 2013;10(1):79-89. doi: 10.7150/ijms.5291. Epub 2012 Dec 22.
- Background: PubMed 29773176Kim HN, Kim SH, Eun YM, Song SW. Effects of zinc, magnesium, and chromium supplementation on cardiometabolic risk in adults with metabolic syndrome: A double-blind, placebo-controlled randomised trial. J Trace Elem Med Biol. 2018 Jul;48:166-171. doi: 10.1016/j.jtemb.2018.03.022. Epub 2018 Mar 30.
- Background: PubMed 19076553Bartlett HE, Eperjesi F. Nutritional supplementation for type 2 diabetes: a systematic review. Ophthalmic Physiol Opt. 2008 Nov;28(6):503-23. doi: 10.1111/j.1475-1313.2008.00595.x.
- Background: PubMed 23683609Abdollahi M, Farshchi A, Nikfar S, Seyedifar M. Effect of chromium on glucose and lipid profiles in patients with type 2 diabetes; a meta-analysis review of randomized trials. J Pharm Pharm Sci. 2013;16(1):99-114. doi: 10.18433/j3g022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rina Agustina, MD, MSc, PhD principal investigator
HNRC-IMERI, Faculty of Medicine Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc, Chromium, Vitamin C, and Copper Supplementation and Standard healthy lifestyle intervention in people with PreDiabetes and Nutrition, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Fasting Blood Glucose (FBG) (time frame: Baseline (at the beginning of study), Intervention Period (3 and 6 months), and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511468, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.