Effect of Oligopin® on Blood Pressure.

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Blood Pressure
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Oligopin®

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Technological Center of Nutrition and Health (CTNS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo; 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: Oligopin®; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Technological Centre of Nutrition and Health, Spain
• Investigators: Study Director: Rosa M VALLS, PhD, University Rovira i Virgili; Principal Investigator: Rosa SOLÀ, MD,PhD, Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Oligo_extract