Zinc, Chromium, Vitamin C, and Copper Combination Supplement for Prediabetes Progression
NCT ID: NCT04511468
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
670 participants
INTERVENTIONAL
2021-06-23
2025-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
QUADRUPLE
Study Groups
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Experimental Group
A combination of Zinc, Chromium, Vitamin C, and Copper (ZCC supplement) with standard healthy lifestyle intervention
Zinc, Chromium, Vitamin C, and Copper Supplementation
Combination of mineral and vitamin supplementation that consist of Zinc, Chromium, Vitamin C, and Copper
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.
Control group
Placebo with standard healthy lifestyle intervention
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
Placebo with inactive ingredients
Interventions
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Zinc, Chromium, Vitamin C, and Copper Supplementation
Combination of mineral and vitamin supplementation that consist of Zinc, Chromium, Vitamin C, and Copper
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
Placebo with inactive ingredients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
65 Years
ALL
Yes
Sponsors
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Blackmores Institute
INDUSTRY
Indonesia University
OTHER
Responsible Party
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Prof Rina Agustina, MD, PhD
dr. Rina Agustina, M.Sc., PhD
Principal Investigators
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Rina Agustina, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
HNRC-IMERI, Faculty of Medicine Universitas Indonesia
Locations
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Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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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.
Jayawardena 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.
Dall 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.
Janghorbani 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.
Aroda 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.
Kelly FJ. Use of antioxidants in the prevention and treatment of disease. J Int Fed Clin Chem. 1998 Mar;10(1):21-3.
Capdor 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.
Ranasinghe 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.
Guo 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.
Kim 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.
Bartlett 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.
Abdollahi 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.
Will 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.
Eriksson J, Kohvakka A. Magnesium and ascorbic acid supplementation in diabetes mellitus. Ann Nutr Metab. 1995;39(4):217-23. doi: 10.1159/000177865.
Ashor 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.
Islam MR, Attia J, Ali L, McEvoy M, Selim S, Sibbritt D, Akhter A, Akter S, Peel R, Faruque O, Mona T, Lona H, Milton AH. Zinc supplementation for improving glucose handling in pre-diabetes: A double blind randomized placebo controlled pilot study. Diabetes Res Clin Pract. 2016 May;115:39-46. doi: 10.1016/j.diabres.2016.03.010. Epub 2016 Mar 19.
Sharma S, Agrawal RP, Choudhary M, Jain S, Goyal S, Agarwal V. Beneficial effect of chromium supplementation on glucose, HbA1C and lipid variables in individuals with newly onset type-2 diabetes. J Trace Elem Med Biol. 2011 Jul;25(3):149-53. doi: 10.1016/j.jtemb.2011.03.003. Epub 2011 May 12.
Paiva AN, Lima JG, Medeiros AC, Figueiredo HA, Andrade RL, Ururahy MA, Rezende AA, Brandao-Neto J, Almeida Md. Beneficial effects of oral chromium picolinate supplementation on glycemic control in patients with type 2 diabetes: A randomized clinical study. J Trace Elem Med Biol. 2015 Oct;32:66-72. doi: 10.1016/j.jtemb.2015.05.006. Epub 2015 May 28.
Vistisen D, Kivimaki M, Perreault L, Hulman A, Witte DR, Brunner EJ, Tabak A, Jorgensen ME, Faerch K. Reversion from prediabetes to normoglycaemia and risk of cardiovascular disease and mortality: the Whitehall II cohort study. Diabetologia. 2019 Aug;62(8):1385-1390. doi: 10.1007/s00125-019-4895-0. Epub 2019 May 23.
Khan MI, Siddique KU, Ashfaq F, Ali W, Reddy HD, Mishra A. Effect of high-dose zinc supplementation with oral hypoglycemic agents on glycemic control and inflammation in type-2 diabetic nephropathy patients. J Nat Sci Biol Med. 2013 Jul;4(2):336-40. doi: 10.4103/0976-9668.117002.
Agustina R, Prafiantini E, Putri AR, Mufida R, Hanifa H, Afifah S, Tahapary DL, Shankar AH, Soewondo P. Protocol for a randomized controlled trial to evaluate the impact of daily supplementation with zinc, chromium, vitamin C, and copper on progression of prediabetes in Jakarta, Indonesia. Contemp Clin Trials. 2025 Sep;156:108007. doi: 10.1016/j.cct.2025.108007. Epub 2025 Jul 11.
Other Identifiers
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CHANGE
Identifier Type: -
Identifier Source: org_study_id
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