Effect of Oligopin® on Blood Pressure.
Sleutelwoorden
Abstract
Datums
| Laatst geverifieerd: | 02/28/2015 |
| Eerste ingediend: | 02/12/2014 |
| Geschatte inschrijving ingediend: | 02/12/2014 |
| Eerst geplaatst: | 02/13/2014 |
| Laatste update ingediend: | 03/16/2015 |
| Laatste update geplaatst: | 03/17/2015 |
| Werkelijke startdatum van het onderzoek: | 10/31/2013 |
| Geschatte primaire voltooiingsdatum: | 10/31/2014 |
| Geschatte voltooiingsdatum van het onderzoek: | 12/31/2014 |
Conditie of ziekte
Interventie / behandeling
Dietary Supplement: Product one
Dietary Supplement: Product two
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| 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 |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | 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. |
Resultaat
Primaire uitkomstmaten
1. Differences detected on the time evolution of BP both in two arms of intervention [5 weeks]
Secundaire uitkomstmaten
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]
