Effect of Oligopin® on Blood Pressure.

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063477
• Other study ID #: Oligo_extract
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2022
• Source: Technological Centre of Nutrition and Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Dietary Supplement:
• Placebo
The placebo composition is for 1 gelule: 250 mg maltodextrin + 30 mg magnesium stearate; total weight: 280 mg/gelule
• 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

Locations

Country	Name	City	State
Spain	Technological Center of Nutrition and Health (CTNS)	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Technological Centre of Nutrition and Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences detected on the time evolution of BP both in two arms of intervention		5 weeks
Secondary	Anthropometric data (Weight, BMI, Waist circumference)		weeks 2, 5, 6, 9
Secondary	Endothelial function (Laser-Doppler)		Weeks 2, 5, 6, 9
Secondary	Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT)		Week 1
Secondary	- Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity)		Weeks 2, 5, 6, 9
Secondary	- 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