A Combination of Zinc, Chromium, Vitamin C, and Copper supplement for Prediabetes Progression: Randomized Controlled-Trial in Jakarta
Tahapan Penelitian : Complete
Sponsor:
Blackmores Institute
Mitra Pelaksana:
Not Specified
No Registry
INA-2EO839HH
Tanggal Input Registry : 25-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 20-06-2021 |
| Outcome Primer | The improvement on measurements of mean levels of glucose profile measured by FBG, HbA1c, 2-hour OGTT and HOMAIR and the reduction of the proportion of subject to the risk of progression to diabetes |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | A Combination of Zinc, Chromium, Vitamin C, and Copper supplement for Prediabetes Progression: Randomized Controlled-Trial in Jakarta |
| Judul Penelitian Ilmiah | A Combination of Zinc, Chromium, Vitamin C, and Copper supplement for Prediabetes Progression: Randomized Controlled-Trial in Jakarta |
| Jenis Penelitian | Interventional |
| Intervensi | The ZCC tablet contains 30 mg of elemental Zinc (from Zinc Sulphate), 50mcg of elemental Chromium (from Chromium Picolinate), 500mg Vitamin C (from Ascorbic Acid and Calcium Ascorbate Dihydrate) and 1 mg of Copper (Copper Gluconate) |
| Jumlah Subyek Penelitian | 670 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Adults aged between 35-65 years old, Being prediabetes as assessed by Having FBG level in the range of 100 mg/dL to 125 mg/dL and having 2-h values in the OGTT level atExclusion Criteria: Pregnancy or lactation women, Transgender on hormonal injection, Bariatric surgery, Consuming other pills supplementation containing zinc and/or chromium, copper, vitamin C and herbal medicines that may have blood glucose effect on a daily basis for the last three month, History of Inflammatory Bowel Disease (IBD), psychiatric disorders, chronic diseases, Not healthy (current status of severe malnourished which is BMI ≤ 16kg/m2, acute problem of any severe disease, history of impaired hepatic, renal failure, heart failure, cancer, other catastrophic disease, Currently using weight loss medication, Consuming pharmacology agents that might interfere the intervention (such as metformin, methylprednisolone, methyl testosterone, diuretics, complementary medicines), Subjects who are unable to read and understand the statements of consent form |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-442/UN2.F1/ETIK/PPM.00.02/2020 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Vicky Achmad Ginanjar |