Effect of Oligopin® on Blood Pressure.
Λέξεις-κλειδιά
Αφηρημένη
Ημερομηνίες
| Τελευταία επαλήθευση: | 02/28/2015 |
| Πρώτα υποβλήθηκε: | 02/12/2014 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 02/12/2014 |
| Δημοσιεύτηκε για πρώτη φορά: | 02/13/2014 |
| Υποβλήθηκε τελευταία ενημέρωση: | 03/16/2015 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 03/17/2015 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 10/31/2013 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 10/31/2014 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 12/31/2014 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Dietary Supplement: Product one
Dietary Supplement: Product two
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Placebo Comparator: Product one 150 mg (maltodextrin)/day (75 mg maltodextrin included in 280 mg/gelule; 2 times/day: morning and evening) of Placebo plus Dietary Approaches to Stop Hypertension (DASH) | Dietary Supplement: Product one The placebo composition is for 1 gelule: 250 mg maltodextrin + 30 mg magnesium stearate; total weight: 280 mg/gelule |
| Active Comparator: Product two 150 mg Oligopin/day (75mg Oligopin included in 280mg/gelule; 2 times/day: morning and evening) of Oligopin® plus Dietary Approaches to Stop Hypertension (DASH) | Dietary Supplement: Product two Oligopin® PUR' expert (%) is a red brown powder extracted from the bark of the Maritime Pine (Pinus pinaster) with composition:
- TOTAL POLYPHENOL CONTENT > 96
MONOMERS + PHENOLIC ACIDS 30
DIMERS >15
OTHER OLIGOMERS 50
PROCYANIDINS CONTENT (GPC) > 67
The Oligopin composition is for 1 gelule: 75 mg Oligopin + 175 mg maltodextrine + 30 mg magnesium stearate: total weight: 280 mg/gelule |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - early stages of hypertension (systolic BP ≥ 140 and ≤ 159 mm Hg) and/or diastolic BP: ≥ 90 and ≤ 99 mm Hg - not receiving BP-lowering medication. - obtained written informed consent before the initial screening visit. Exclusion Criteria: - Body Mass Index (BMI) > 30 kg/m2 - taking antihypertensive medications - smoking - pregnant or who intends to become pregnant - wife in breastfeeding period - persons with a self-reported history of clinical cardiovascular disease, cancer, chronic kidney disease (or a serum creatinine ≥ 1.7 mg/dL for men and ≥ 1.5 mg/dL for women) hypercholesterolemia (LDL-c ≤ 189 mg/dL, diabetes mellitus (or serum glucose ≥126 mg/dL), or consumption of more than 14 drinks of alcoholic beverages per week. |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Differences detected on the time evolution of BP both in two arms of intervention [5 weeks]
Δευτερεύοντα αποτελέσματα
1. Anthropometric data (Weight, BMI, Waist circumference) [weeks 2, 5, 6, 9]
2. Endothelial function (Laser-Doppler) [Weeks 2, 5, 6, 9]
3. Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT) [Week 1]
4. - Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity) [Weeks 2, 5, 6, 9]
5. - Biomarker related with inflammatory processes (High sensitive C Reactive Protein) - Biomarkers of antioxidant system (Oxidised- LDL levels, Reduced glutathione, Oxidised glutathione, Ratio Glutathione balance) [Weeks 2, 5, 6, 9]
