Effect of Oligopin® on Blood Pressure.

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a French Maritim Pine Bark Extract Oligopin® on Blood Pressure: Double Blind, Crossover, Placebo-controlled Nutrition Intervention Trial

Conditions
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Blood Pressure, Hypertension

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Oligopin®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Product one<br>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: Placebo<br>* The placebo composition is for 1 gelule: 250 mg maltodextrin + 30 mg magnesium stearate; total weight: 280 mg/gelule<br>|
| Active Comparator: Product two<br>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: Oligopin®<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences detected on the time evolution of BP both in two arms of intervention |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |