Cardiovascular Risk FactorsPhase 3PHENOLPRESSNCT02628353
Effect of a Specific Phenolic Compound on Blood Pressure
A Phase 3 study testing phenolic compound in people with Cardiovascular Risk Factors and Blood Pressure, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial summary
The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic BP after ingestion of a high fat meal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Blood Pressure
- What is being tested?
- phenolic compound
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Mar 2017
- Phase
- Phase 3
- 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
- Adults men or women (>18 years old)
- Blood pressure (with no drug intervention) ≥130 mm Hg systolic blood pressure ≤ 159 mmHg
- No evidence of chronic disease
- Written informed consent provided before the initial screening visit.
Who cannot join
- Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥100 mm Hg or taking antihypertensive medication
- Body mass index (BMI) ≥ 35 kg/m2
- Glucose (fasting state) >125 mg/dL
- LDL-cholesterol >189 mg/dL
- Triglycerides >350 mg/dL
- Pregnant or intending to become pregnant
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- Use of medication, antioxidant, or multi-vitamin supplements
- Chronic alcoholism
- Intense physical activity (5h/week)
- Intestinal disorders
- Following of a vegetarian diet
- Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
- Being intolerant or suffer from allergy to any of the products of the high fat meal (white bread, olive oil, boiled egg, cheese) or to the products of the study.
- Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
- Failure to follow the study guidelines.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Technological Centre of Nutrition and Health (CTNS)
Reus, Tarragona, 43204
Rosa Maria Valls, PhD, +34 636 944 723, estudis@ctns.cat
Ignasi Papell, BSc, +34 977 300 431, estudis@ctns.cat
About this study
Official title: Randomized, Cross-over, Double Blinded, Placebo-controlled Study for the Evaluation of the Postprandial Effect of a Specific PHENOLic Compound on Blood PRESSure
The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic BP after ingestion of a high fat meal.
Read the detailed description
The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic blood pressure (BP) after ingestion of a high fat meal.
The secondaries objectives are:
- To evaluate the effects on diastolic BP.
- To study the phenolic compound bioavailability and to analyze its metabolites for determine the phenolic compound consumption biomarkers.
- To evaluate the effects on endothelial function by ischemic reactive hyperemia (IRH).
The sample size was calculated using a previous studies using systolic blood pressure (SBP) as the primary outcome measure. A total of 14 subjects are needed, assuming variance components of approximately 20.0, to detect differences between treatments (placebo and phenolic product) of 10 mmHg, with a bilateral significance level of α=0.05, a power of 80% and a standard deviation of 11.82 mmHg at the baseline.
To compare the main variable efficiency of the products of study as well as secondary variables of efficiency, will carry out analysis of the covariance (ANCOVA) with basal value as covariable, followed by the Tukey test for determining multiple differences. All tests will be carried out with significance to bilateral level of 5%. It is considered significant value p<0,05. The data will be analyzed using the "SPSS" program version 22.
The statistical analysis will follow the principles specified in the guidelines of the International Conference on Harmonization (ICH) E9 and CPMP/EWP/908/99 ICH E9 Points to Consider on Multiplicity Issues in Clinical Trials.
- Conditions
- Cardiovascular Risk Factors, Blood Pressure
- Being tested
- placebo, phenolic compound
- Keywords
- Cardiovascular diseases, endothelial function, systolic blood pressure, metabolomics, cardiovascular risk factor, bioavailability, phenolic compounds, hypertension
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
1 capsule of placebo product (100 mg carboxymetylcellulose) in one visit
phenolic compoundDietary supplement
1 capsule of phenolic compound product (100mg phenolic compound + 100 mg carboxymetylcellulose) in one visit
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | control group Receives: Dietary Supplement: placebo |
| Phenolic compound | Experimental | treated group Receives: Dietary Supplement: phenolic compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Systolic Blood Pressure
During each visit (2 visits in total), systolic BP will be measured after 10 min in a seated position in a comfortable room by the physician. The measurement will be taken in triplicate at 1-min intervals using an automatic sphygmomanometer (OMRON HEM-907; PEROXFARMA, Barcelona, Spain). The first measurement will be discarded and the final result will be the average of the other measurements..
The research team will mesure the change in the evolution of systolic blood pressure between visits (at least 1 week between visits).
Measured: In each visit (2 visits in total), systolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.
Secondary outcomes (4)
Diastolic Blood Pressure
During each visit (2 visits in total), diastolic BP will be measured after 10 min in a seated position in a comfortable room by the physician. The measurement will be taken in triplicate at 1-min intervals using an automatic sphygmomanometer (OMRON HEM-907; PEROXFARMA, Barcelona, Spain). The first measurement will be discarded and the final result will be the average of the other measurements..
The research team will mesure the change in the evolution of diastolic blood pressure between visits (at least 1 week between visits).
Measured: In each visit (2 visits in total), diastolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.
Ischemic reactive hyperemia (IRH)
The endothelial-dependent vasomotor functions will be measured as IRH by a Laser-Doppler linear PERIFLUX 5000 flowmeter (PERIMED AB, Stockholm, Sweden)
Measured: In each visit (2 visits in total), at 0, 120, 240 and 360 minutes
Bioavailability of phenolic compound in plasma samples
The phenolic compound bioavailability will be analysed in all volunteers and according to the technical reference at the time of its determination, as it may be to analyse automatic, ELISA kits, or other techniques.
Measured: In each visit (2 visits in total), at 0, 60, 120, 180, 240, 300 and 360 minutes (heparin lithium plasma)
Bioavailability of phenolic compound in urine
The phenolic compound bioavailability will be analysed according to the technical reference at the time of its determination, as it may be to analyse automatic, ELISA kits, or other techniques
Measured: In each visit (2 visits in total), at 0, 180 and 360 minutes (total urine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- University Rovira i Virgili, Hospital Universitari Sant Joan de Reus, Fundació Catalana per a la Recerca i la Innovació (FCRI)
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, PhD, Principal investigator, University Rovira i Virgili / Hospital Universitari Sant Joan de ReusBegoña Muguerza, PhD, Study chair, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628353
- Sponsor's protocol ID
- LLAVOR 2014-00081
- Acronym
- PHENOLPRESS
- Status last verified
- Jan 2017
- First submitted
- 3 Dec 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Cross-over, Double Blinded, Placebo-controlled Study for the Evaluation of the Postprandial Effect of a Specific PHENOLic Compound on Blood PRESSure
- ClinicalTrials.gov ID
- NCT02628353
- Acronym / sponsor ID
- PHENOLPRESS / LLAVOR 2014-00081
- Conditions
- Cardiovascular Risk Factors, Blood Pressure
- Keywords
- Cardiovascular diseases, endothelial function, systolic blood pressure, metabolomics, cardiovascular risk factor, bioavailability, phenolic compounds, hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Collaborators
- University Rovira i Virgili, Hospital Universitari Sant Joan de Reus, Fundació Catalana per a la Recerca i la Innovació (FCRI)
- Study start
- Dec 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 11 Dec 2015 (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 study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic BP after ingestion of a high fat meal.
Detailed description
The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic blood pressure (BP) after ingestion of a high fat meal.
The secondaries objectives are:
- To evaluate the effects on diastolic BP.
- To study the phenolic compound bioavailability and to analyze its metabolites for determine the phenolic compound consumption biomarkers.
- To evaluate the effects on endothelial function by ischemic reactive hyperemia (IRH).
The sample size was calculated using a previous studies using systolic blood pressure (SBP) as the primary outcome measure. A total of 14 subjects are needed, assuming variance components of approximately 20.0, to detect differences between treatments (placebo and phenolic product) of 10 mmHg, with a bilateral significance level of α=0.05, a power of 80% and a standard deviation of 11.82 mmHg at the baseline.
To compare the main variable efficiency of the products of study as well as secondary variables of efficiency, will carry out analysis of the covariance (ANCOVA) with basal value as covariable, followed by the Tukey test for determining multiple differences. All tests will be carried out with significance to bilateral level of 5%. It is considered significant value p<0,05. The data will be analyzed using the "SPSS" program version 22.
The statistical analysis will follow the principles specified in the guidelines of the International Conference on Harmonization (ICH) E9 and CPMP/EWP/908/99 ICH E9 Points to Consider on Multiplicity Issues in Clinical Trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: placebocontrol group |
| Phenolic compound | Experimental | Dietary Supplement: phenolic compoundtreated group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults men or women (>18 years old)
- Blood pressure (with no drug intervention) ≥130 mm Hg systolic blood pressure ≤ 159 mmHg
- No evidence of chronic disease
- Written informed consent provided before the initial screening visit.
Key exclusion criteria (15 listed)
- Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥100 mm Hg or taking antihypertensive medication
- Body mass index (BMI) ≥ 35 kg/m2
- Glucose (fasting state) >125 mg/dL
- LDL-cholesterol >189 mg/dL
- Triglycerides >350 mg/dL
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 |
|---|---|---|
| placebo1 capsule of placebo product (100 mg carboxymetylcellulose) in one visit | Dietary supplement | Placebo |
| phenolic compound1 capsule of phenolic compound product (100mg phenolic compound + 100 mg carboxymetylcellulose) in one visit | Dietary supplement | Phenolic compound |
Primary outcome
Change of Systolic Blood Pressure
Time frame: In each visit (2 visits in total), systolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.
During each visit (2 visits in total), systolic BP will be measured after 10 min in a seated position in a comfortable room by the physician. The measurement will be taken in triplicate at 1-min intervals using an automatic sphygmomanometer (OMRON HEM-907; PEROXFARMA, Barcelona, Spain). The first measurement will be discarded and the final result will be the average of the other measurements.. The research team will mesure the change in the evolution of systolic blood pressure between visits (at least 1 week between visits).
4 secondary outcomes
Diastolic Blood Pressure
Time frame: In each visit (2 visits in total), diastolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.
Ischemic reactive hyperemia (IRH)
Time frame: In each visit (2 visits in total), at 0, 120, 240 and 360 minutes
Bioavailability of phenolic compound in plasma samples
Time frame: In each visit (2 visits in total), at 0, 60, 120, 180, 240, 300 and 360 minutes (heparin lithium plasma)
Bioavailability of phenolic compound in urine
Time frame: In each visit (2 visits in total), at 0, 180 and 360 minutes (total urine)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Technological Centre of Nutrition and HealthLink provided by the sponsor.
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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 Solà, PhD principal investigator
University Rovira i Virgili / Hospital Universitari Sant Joan de Reus
Begoña Muguerza, PhD study chair
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing phenolic compound in people with Cardiovascular Risk Factors and Blood Pressure, 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 Feb 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosa Maria Valls, PhD (+34977759377/636944723, estudis@ctns.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Systolic Blood Pressure (time frame: In each visit (2 visits in total), systolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2017.