Blood PressureNCT02063477
Effect of Oligopin® on Blood Pressure.
A study testing Oligopin® in people with Blood Pressure and Hypertension, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension
- What is being tested?
- Oligopin®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Technological Center of Nutrition and Health (CTNS)
Reus, Tarragona, 43204
About this study
Official title: 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.
- Conditions
- Blood Pressure, Hypertension
- Being tested
- Placebo, Oligopin®
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Oligopin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences detected on the time evolution of BP both in two arms of intervention
Measured: 5 weeks
Secondary outcomes (5)
Anthropometric data (Weight, BMI, Waist circumference)
Measured: weeks 2, 5, 6, 9
Endothelial function (Laser-Doppler)
Measured: Weeks 2, 5, 6, 9
Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT)
Measured: Week 1
- Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity)
Measured: 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)
Measured: Weeks 2, 5, 6, 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa M VALLS, PhD, Study director, University Rovira i VirgiliRosa SOLÀ, MD,PhD, Principal investigator, Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063477
- Sponsor's protocol ID
- Oligo_extract
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2014
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 27765365
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a French Maritim Pine Bark Extract Oligopin® on Blood Pressure: Double Blind, Crossover, Placebo-controlled Nutrition Intervention Trial
- ClinicalTrials.gov ID
- NCT02063477
- Acronym / sponsor ID
- Oligo_extract
- Conditions
- Blood Pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product one | Placebo comparator | Dietary Supplement: Placebo150 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 | Active comparator | Dietary Supplement: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Body Mass Index (BMI) > 30 kg/m2
- taking antihypertensive medications
- smoking
- pregnant or who intends to become pregnant
- wife in breastfeeding period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe placebo composition is for 1 gelule: 250 mg maltodextrin + 30 mg magnesium stearate; total weight: 280 mg/gelule | Dietary supplement | Product one |
| 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 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 | Dietary supplement | Product two |
Primary outcome
Differences detected on the time evolution of BP both in two arms of intervention
Time frame: 5 weeks
5 secondary outcomes
Anthropometric data (Weight, BMI, Waist circumference)
Time frame: weeks 2, 5, 6, 9
Endothelial function (Laser-Doppler)
Time frame: Weeks 2, 5, 6, 9
Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT)
Time frame: Week 1
- 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
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 27765365Valls 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa M VALLS, PhD study director
University Rovira i Virgili
Rosa SOLÀ, MD,PhD principal investigator
Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligopin® in people with Blood Pressure and Hypertension, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences detected on the time evolution of BP both in two arms of intervention (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.