About this trial
The primary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing FPG compared to baseline and to recommended standard diet alone after 3 months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI ≤30 kg/m2
subjects able to understand the informed consent and sign it before enrollment in the study
subjects willing to follow all study requirements and perform all study visits as well as collaborate with the investigator.
Disqualifiers
ongoing treatment with drugs that can affect blood glucose
current participation in another investigational drug or investigational device trial or inclusion in another investigational drug or investigational device trial within the previous month
Trial design
Parallel
Treatments tested in this trial
Nutraceutical supplements
Dietary supplementAn association of banaba leaves extract and chromium picolinate (Euglycem®) will be administered
Placebo
Dietary supplementPlacebo
Treatment groups
Trial outcomes
Primary outcomes
Dysglicemia
The primary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing FPG compared to baseline and to recommended standard diet alone after 3 months of supplementation.
Secondary outcomes
Insulin reistance
The secondary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing HbA1c, FPI and HOMA index
Vitamin D3 levels
The secondary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on the variation of vitamin D3 levels
Glycemic status
The secondary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on the proportion of subjects pass from impaired fasting glycemia (IFG) condition to euglycemia and the proportion of subjects pass from impaired glucose tolerance (IGT) condition to euglycemia
Sponsors and contacts
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