Inadequate diet for protective factors for vascular system MedDRA version: 9.1 Level: LLT Classification code 10021577 Term: Inadequate diet
Conditions
Interventions
Product Name: OLEASELECT
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Tablet
Route of admini
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18-65 age healthy volunteers if their dietary habits will correspond to the lowest values (Iowest tertile) of the score measuring the adherence to the Mediterranean diet Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: vegetarian, pregnant women, history of previous cardiovascular disease, severe hypertension (SBP>180 and/or DBP >110 mmHG), severe diabetes (blood glucose >250 mg/dl), severe dyslipidemia (Chol > 350 mg/dl or TG> 400 mg/dl), body mass index (in kg/m2) >35, major diseases, chronic use of drugs or use of drugs in the 2 weeks prior to the inclusion into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the feasibility of a clinical trial to establish the ability of OleaSelect after repeated oral administration to influence metabolic pathways related to atherosclerosis and thrombosis and their response to a stress condition such as a fat meal in healthy human subjects.;Secondary Objective: nd;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed