Carbohydrate metabolism Nutritional, Metabolic, Endocrine
Conditions
Interventions
The study recruited 62 subjects (31 subjects per group), that were randomized into the following experimental groups:
GROUP 1: subjects who had to take two tablets of the food supplement based on ext
Sponsors
ESSERRE Pharma S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-diabetic subjects, as determined by clinical history and information provided during recruitment, aged between 18 and 75 years. 2. Subjects with impaired fasting glucose (IFG) between 100 and 125 mg/dL. 3. Subjects able to understand and willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Aged 75 years 2. Subjects exposed to a high risk of cardiovascular events based on 8 risk factors (gender, age, diabetes, smoking habits, systolic blood pressure, total cholesterol, HDL-cholesterolemia and antihypertensive treatment) in accordance with the parameters of the Cuore project of the Istituto Superiore di Sanità (http://www.cuore.iss.it/sopra/calc-rischio.asp) 3. BMI > 30, indicated as the threshold value for the definition of an obese subject (https://www.salute.gov.it/portale/nutrizione/dettaglioIMCNutrizione.jsp?lingua=italiano&id=5479&area=nutrizione&menu=vuoto) 4. In drug therapy for diabetes even at low doses 5. Intake of blood glucose supplements in the two weeks prior to recruitment 6. Women who were pregnant, suspect they were pregnant or planned to become pregnant 7. Breastfeeding women 8. Blood donors in the three months prior to recruitment 9. Not self-sufficient 10. Who showed no inclination to collaborate 11. Who had difficulty reaching the reference facility within the expected times 12. Who were not considered suitable by the investigating physician due to the presence of other pathologies deemed incompatible with enrollment 13. With a history of allergy to the ingredients contained in the treatments under study (food supplement and placebo) 14. History of addiction or abuse of medications, drugs or alcohol 15. Smokers (electronic devices with nicotine or cigarettes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of fasting blood glucose in peripheral blood samples at baseline (t0), 90 days (t1), and 180 days (t2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Glycated hemoglobin (HbA1c) levels are measured using high-performance liquid chromatography (HPLC) at baseline (t0), 90 days (t1), and 180 days (t2) 2. Fasting insulin levels are measured using immunoassay at baseline (t0), 90 days (t1), and 180 days (t2) 3. Insulin resistance is measured using the HOMA-IR index calculated from fasting glucose and insulin levels at baseline (t0), 90 days (t1), and 180 days (t2) 4. Total cholesterol is measured using enzymatic colorimetric assay at baseline (t0), 90 days (t1), and 180 days (t2) 5. LDL cholesterol is measured using direct enzymatic assay at baseline (t0), 90 days (t1), and 180 days (t2) 6. HDL cholesterol is measured using direct enzymatic assay at baseline (t0), 90 days (t1), and 180 days (t2) 7. Triglycerides are measured using enzymatic colorimetric assay at baseline (t0), 90 days (t1), and 180 days (t2) 8. Body mass index (BMI) is measured using weight and height data at baseline (t0), 90 days (t1), and 180 days (t2) 9. Systolic and diastolic blood pressure are measured using automated sphygmomanometer at baseline (t0), 90 days (t1), and 180 days (t2) 10. Waist circumference is measured using a standard measuring tape at baseline (t0), 90 days (t1), and 180 days (t2) 11. White blood cell count is measured using automated hematology analyzer at baseline (t0), 90 days (t1), and 180 days (t2) 12. Erythrocyte sedimentation rate (ESR) is measured using the Westergren method at baseline (t0), 90 days (t1), and 180 days (t2) 13. C-reactive protein is measured using high-sensitivity immunoassay at baseline (t0), 90 days (t1), and 180 days (t2) 14. Alanine aminotransferase (ALT/SGPT) is measured using enzymatic assay at baseline (t0), 90 days (t1), and 180 days (t2) 15. Aspartate aminotransferase (AST/SGOT) is measured using enzymatic assay at baseline (t0), 90 days (t1), and 180 days (t2) 16. Serum creatinine is measured using the Jaffe method or enzymatic assay at baseline (t0), 90 days | — |
Countries
Italy
Contacts
Public ContactAlessandra ;Lorenza Francesca Baldi;De Lellis
;
Outcome results
None listed