Dysglycemia including impaired fasting glucose (fasting blood glucose =100 and <126 mg/dL) and impaired glucose tolerance (blood glucose levels =140 mg/dL and <200 mg/dL after 120 minutes of an oral glucose tolerance test). Nutritional, Metabolic, Endocrine
Conditions
Interventions
Patients are randomly allocated to three intervention groups:
1. Placebo (PL) group: Participants in the placebo group will consume two placebo infusions per day (one with lunch and one with dinner) f
Sponsors
NGN Healthcare—New Generation Nutraceuticals s.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female participants of Caucasian ethnicity, aged between 18 and 75 years 2. Dysglycemia, defined as impaired fasting glucose (fasting blood glucose between 100 and 126 mg/dL) and/or Impaired Glucose Tolerance (blood glucose levels =140 mg/dL and 20 and <35 kg/m² 4. Ability to understand and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. HbA1c > 6.5% 2. Total cholesterol > 250 mg/dL and triglycerides > 200 mg/dL 3. Cardiovascular events (myocardial infarction and/or stroke) in the last 6 months 4. Renal insufficiency (creatinine > 1.5 mg/dL) and hepatic insufficiency (ALT/AST and/or gamma-glutamyl transpeptidase (?-GT) twice above normal values) 5. Anemia (Hb 3 kg in the previous 3 months 9. Malignant neoplasms 10. Significant neurological or psychiatric disorders, including alcohol or drug abuse 11. Patients on therapy with: hypoglycemic agents (both pharmaceutical and nutraceutical), laxatives, ß-agonists (except inhalers), cyproheptadine, antidepressants, antiserotonergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics 12. Pregnant or breastfeeding women, or women of childbearing age not using adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum glycated hemoglobin (HbA1c) level measured using a commercially available kit (InterMedical s.r.l, Italy) in blood samples collected at baseline and after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will evaluate several metabolic and health-related markers at baseline and 4, 8, and 12 weeks of treatment: 1. Fasting glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, AST (aspartate aminotransferase), and ALT (alanine aminotransferase) measured using commercially available kits (Diacron International, Italy) 2. Fasting insulin levels, measured using an enzyme-linked immunosorbent (ELISA) assay commercial kit (InterMedical s.r.l, Italy) 3. Homeostatic model assessment of insulin resistance (HOMA index), calculated with the formula: fasting glucose (mg/dl) times fasting insulin (µUI/ml) divided by 22.5 4. The quality of life of participants measured using the SF-12 health survey questionnaire at baseline and after 4, 8 and 12 weeks of treatment | — |
Countries
Italy
Contacts
Public ContactElisabetta Schiano
Outcome results
None listed