Effect of Oligopin® on Blood Pressure.

NCT02063477 | Completed DMC

• 1 other identifier: Oligo_extract
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Hypertension

Outcome Measures

Primary Outcomes (1)

• Differences detected on the time evolution of BP both in two arms of intervention

  5 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Product one

PLACEBO COMPARATOR

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

Product two

ACTIVE COMPARATOR

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®

Interventions

Placebo DIETARY_SUPPLEMENT

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

Product one

Oligopin® DIETARY_SUPPLEMENT

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

Product two

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technological Centre of Nutrition and Health, Spain: lead

Study Sites (1)

Technological Center of Nutrition and Health (CTNS)

Reus, Tarragona, 43204, Spain

Location

Related Publications (1)

• 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.

  PMID: 27765365 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Oligopin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rosa M VALLS, PhD

  University Rovira i Virgili

  STUDY DIRECTOR

• Rosa SOLÀ, MD,PhD

  Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 14, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

ES (1)