Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
Patients are randomly allocated to three intervention groups: placebo (PL) group (500 mg of maltodextrins three times/day), low dose of TN (LD) group (500 mg of TN three times/day, lyophilized), or hi
Sponsors
Samnium Medical Cooperative (Benevento, Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18–83 years. 2. Clinical diagnosis of type 2 diabetes mellitus (T2DM) according to American Diabetes Association (ADA).
Exclusion criteria
Exclusion criteria: 1. Smokers 2. Hepatic disease 3. Renal disease 4. Heart disease 5. Type 1 diabetes mellitus (T1DM) 6. Family history of chronic diseases 7. Drug therapy or supplement intake containing polyphenols 8. Heavy physical exercise (over 10 hours per week) 9. Underweight (Body Mass Index <18.5 kg/m²) 10. Pregnant, suspected of being pregnant or hoping to become pregnant 11. Breastfeeding 12. Birch pollen allergy 13. Use of vitamin or mineral supplements 2 weeks prior to entry into the study 14. Donation of blood less than 3 months prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the evaluation of the primary outcomes, blood samples were collected after 12 h of fasting at 0 and 12 weeks in 10-mL EDTA coated tubes, and plasma was immediately isolated by centrifugation (20 min, 2.200 g, 4°C). All samples were stored at -80°C until analysis. 1. Fasting plasma glucose (FPG), determined using commercially available kits (Diacron International, Italy). 2. Glycated hemoglobin (HbA1c), determined with a commercially available kit (InterMedical s.r.l, Italy). 3. Fasting plasma insulin (FPI), measured using an enzyme-linked immunosorbent (ELISA) assay commercial kit (InterMedical s.r.l, Italy). 4. Homeostatic model assessment of insulin resistance (HOMA index), calculated with the formula: FPG (mg/dl) times FPI (µUI/ml) divided by 22.5. 5. Abscisic acid (ABA) plasma levels, assessed using liquid chromatography/mass spectrometry (LC/MS) analysis of blood samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Unless otherwise stated, the following are assessed at 0 and 12 weeks: 1. Clinical history, assessed by interviews and analysis of previous clinical data at the baseline. 2. Nutrient intake and dietary habits, assessed using a seven-day food record validated nutritional questionnaire at the baseline and at the end of the study period. 3. Anthropometric measures, collected by measuring height, weight, and waist circumference (WC). 4. Blood pressure, assessed using a blood pressure cuff. 5. Plasma total cholesterol (TC), measured from using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International. 6. high-density lipoprotein-cholesterol (HDL-C), measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International. 7. Low-density lipoprotein-cholesterol (LDL-C), measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International. 8. Triglyceride levels, measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International. 9. Aspartate transaminase (AST), measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International. 10. Aspartate transaminase (AST), measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International. 11. Creatine levels, measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International. | — |
Countries
Italy
Contacts
Public ContactElisabetta Schiano
Outcome results
None listed