Blood Pressure, Hypertension
Conditions
Brief summary
The objective of the study is to evaluate the effect of consumption of a food supplement rich in procyanidins extracted from the bark of French pine, Oligopin®, on blood pressure of people with mild / moderate degree of hypertension. Furthermore, the effect Oligopin® consumption on markers involved in the development of hypertension, and endothelial function in key enzymes that regulate blood pressure, inflammation and oxidation are considered. Also, try to advance the understanding of the molecular mechanisms that regulate blood pressure.
Interventions
DIETARY_SUPPLEMENTPlacebo
The placebo composition is for 1 gelule: 250 mg maltodextrin + 30 mg magnesium stearate; total weight: 280 mg/gelule
DIETARY_SUPPLEMENTOligopin®
Oligopin® PUR' expert (%) is a red brown powder extracted from the bark of the Maritime Pine (Pinus pinaster) with composition: \- TOTAL POLYPHENOL CONTENT \> 96 1. MONOMERS + PHENOLIC ACIDS 30 2. DIMERS \>15 3. 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
Sponsors
Technological Centre of Nutrition and Health, Spain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences detected on the time evolution of BP both in two arms of intervention | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric data (Weight, BMI, Waist circumference) | weeks 2, 5, 6, 9 |
| Endothelial function (Laser-Doppler) | Weeks 2, 5, 6, 9 |
| Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT) | Week 1 |
| - Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity) | Weeks 2, 5, 6, 9 |
| - 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 |
Countries
Spain
Outcome results
None listed