Clinical trial NCT02063477: Effect of Oligopin® on Blood Pressure.
Official title: Effect of a French Maritim Pine Bark Extract Oligopin® on Blood Pressure: Double Blind, Crossover, Placebo-controlled Nutrition Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Differences detected on the time evolution of BP both in two arms of intervention
timeFrame: 5 weeks
Secondary outcomes:
measure: Anthropometric data (Weight, BMI, Waist circumference)
timeFrame: weeks 2, 5, 6, 9
measure: Endothelial function (Laser-Doppler)
timeFrame: Weeks 2, 5, 6, 9
measure: Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT)
timeFrame: Week 1
measure: - Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity)
timeFrame: Weeks 2, 5, 6, 9
measure: - Biomarker related with inflammatory processes (High sensitive C Reactive Protein) - Biomarkers of antioxidant system (Oxidised- LDL levels, Reduced glutathione, Oxidised glutathione, Ratio Glutathione balance)
timeFrame: Weeks 2, 5, 6, 9
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Technological Center of Nutrition and Health (CTNS)
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili
name: Rosa M VALLS, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS
name: Rosa SOLÀ, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valls RM, Llaurado E, Fernandez-Castillejo S, Puiggros F, Sola R, Arola L, Pedret A. Effects of low molecular weight procyanidin rich extract from french maritime pine bark on cardiovascular disease risk factors in stage-1 hypertensive subjects: Randomized, double-blind, crossover, placebo-controlled intervention trial. Phytomedicine. 2016 Nov 15;23(12):1451-1461. doi: 10.1016/j.phymed.2016.08.007. Epub 2016 Aug 23.