Status:
ACTIVE_NOT_RECRUITING
Zinc, Chromium, Vitamin C, and Copper Combination Supplement for Prediabetes Progression
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
Blackmores Institute
Conditions:
PreDiabetes
Nutrition
Eligibility:
All Genders
35-65 years
Phase:
PHASE2
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 ...
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 betw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT04511468
Start Date
June 23 2021
End Date
March 31 2025
Last Update
November 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 10430