Impaired fasting plasma glucose (fasting plasma glucose between 90 and 120 mg/dL) Nutritional, Metabolic, Endocrine
Conditions
Interventions
The subjects recruited in the present clinical study will consume a food supplement based on Moradyn® (purple corn variety extract Zea mays L. fruit), Gymnema sylvestre (Retz.) R.Br. ex Sm. leaves, zi
after 90 days of treatment = t2) in an outpatient
Sponsors
National Inter-university Consortium of Research in Innovative Pharmaceutical Technologies - Tefarco Innova
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old of both sexes 2. Able to understand and sign the informed consent 3. 98 mg/dL < impaired fasting glycemia < 125 mg/dL
Exclusion criteria
Exclusion criteria: 1. Aged 75 years old 2. A medical history or condition that could affect the subject's safety or negatively impact the validity of the study results 3. Pregnant or breastfeeding women 4. With a history of allergy to ingredients contained in the study treatments (dietary supplement and placebo) 5. Exposed to a high risk of cardiovascular events based on 8 risk factors (sex, age, diabetes, smoking habits, systolic blood pressure, total cholesterolemia, hdl-cholesterolemia and antihypertensive treatment) 6. Following drug therapy for diabetes even at low dosages 7. Taking supplements to control cholesterol, blood sugar and metabolic syndrome, in the two weeks prior to recruitment 8. Women who suspect pregnant or planning pregnancy 9. Blood donors in the three months prior to recruitment 10. Non-self-sufficient individuals 11. Who does not show a propensity to collaborate 12. Who have difficulty getting to the reference facility within the scheduled time 13. Who are not considered suitable by the investigators due to the presence of other pathologies considered incompatible with enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in fasting plasma glucose levels measured using blood tests for fasting serum glucose levels, HbA1c, fasting serum insulin levels and HOMA Index at baseline (t0), 90 days of treatment (t2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Beneficial effect on lipid metabolism measured using the determination of blood levels of total cholesterol (TC), Low-Density Lipoproteins (LDL-C) cholesterol, High-Density Lipoprotein (HDL-C) cholesterol, Triglycerides (TG) at baseline (t0), 90 days of treatment (t2) 2. Height/weight assessment to calculate BMI at baseline (t0), 90 days of treatment (t2) 3. Liver and kidney toxicity measured using blood tests for the biomarkers aspartate transaminase (AST or SGOT), alanine transaminase (ALT or SGPT), and creatinine at baseline (t0), 30 days of treatment (t1), 90 days of treatment (t2). | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed