Measuring the Impact of Dietary Supplementation With a New Baking Product on Gut Microbiota and Cholesterol Metabolism

Study hypothesis: Diet integrated with food prepared with olive, buckwheat, peas and chestnut flour as in PreBIOil product combination can modify the gut microbiota and the cholesterol metabolism. Primary objectives of the study are to assess whether the test product to be able to change: 1. fecal microbiota profile; 2. Plasma cholesterol LDL, total, total LDL and HDL ratio; 3. plasma triglycerides; 4. Apolipoprotein ApoA-I, ApoB, and Lp. Secondary objectives of the study are: 1. anthropometric indices; 2. secondary metabolites of polyphenols in human biofluids; 3. mass spectrometry plasma and urine metabolite profile; 4. blood glucose and fasting insulin levels; 5,6) C-reactive protein (PRC or hsPRC); 7\) urinary isoprostane F2; 8) oxidized LDL in plasma. Study Design: placebo-controlled, randomized, double-blind parallel trial. Inclusion criteria: Aged 30-65 years; BMI 20-29,9 kg/m\^2. Total Cholesterol 180-240 mg/dl Exclusion criteria: Fasting blood glucose \>150 mg/dl; triglycerides \>500 mg/dl; uncontrolled hypertension (blood pressure \[BP\] \>160/100 mm Hg under antihypertensive therapy); any long term medical therapy; food intolerances; alcohol intake \>5 drinks per day or use of narcotic substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco smoking. Methodology: Determination of eligibility: for each volunteer aged between 30 and 65 years, will undergo to clinical and biochemistry evaluation. Clinical visit, clinical tests, and blood drawing will be performed after an overnight fasting at visit T-1 at the Casa di Cura Eremo di Arco (TN). In this T-1 visit the eligibility will be established and the participants will be randomized to receive supplementation with either PreBIOil biscuit (90g/day) or Control for 8 weeks in a double-blind manner. Clinical tests, blood drawing, and stool and urine collection will be performed during visits at the beginning and end of each treatment period (T0 and T1). A 4 day-food