Effect of Oligopin® on Blood Pressure.

Not Applicable

Completed

• Conditions: Blood Pressure; Hypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Oligopin®

• Registration Number: NCT02063477
• Lead Sponsor: Technological Centre of Nutrition and Health, Spain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Product one	Placebo	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)
Product two	Oligopin®	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)

Primary Outcome Measures

Name	Time	Method
Differences detected on the time evolution of BP both in two arms of intervention	5 weeks

Secondary Outcome Measures

Name	Time	Method
- 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
Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT)	Week 1
Anthropometric data (Weight, BMI, Waist circumference)	weeks 2, 5, 6, 9
Endothelial function (Laser-Doppler)	Weeks 2, 5, 6, 9
- Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity)	Weeks 2, 5, 6, 9

Trial Locations

Locations (1)

Technological Center of Nutrition and Health (CTNS); 🇪🇸 Reus, Tarragona, Spain