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Completed

NCT Number: NCT02063477

Effect of Oligopin® on Blood Pressure.

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.

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Key information

Conditions

Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technological Center of Nutrition and Health (CTNS)

Reus, Tarragona, 43204, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

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

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
  • 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

Primary outcomes

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

    Time frame: 5 weeks

Secondary outcomes

  1. Anthropometric data (Weight, BMI, Waist circumference)

    Time frame: weeks 2, 5, 6, 9

  2. Endothelial function (Laser-Doppler)

    Time frame: Weeks 2, 5, 6, 9

  3. Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT)

    Time frame: Week 1

  4. - Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity)

    Time frame: Weeks 2, 5, 6, 9

  5. - Biomarker related with inflammatory processes (High sensitive C Reactive Protein) - Biomarkers of antioxidant system (Oxidised- LDL levels, Reduced glutathione, Oxidised glutathione, Ratio Glutathione balance)

    Time frame: Weeks 2, 5, 6, 9

Sponsors and collaborators

Lead sponsor

Technological Centre of Nutrition and Health, Spain

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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