Borderline HypertensionPhase 2NCT01690676
Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function
A Phase 2 study testing Epicatechin and Microcrystalline cellulose in people with Borderline Hypertension, run by Danisco at 1 site in Finland.
Trial summary
Effect of apple polyphenols on FMD. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Hypertension
- What is being tested?
- Epicatechin and Microcrystalline cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2012to May 2013
- Phase
- Phase 2
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Borderline hypertension
- Otherwise healthy
- Aged 40-65 years (inclusive)
- Not consuming high amounts (over 20 mg daily) of flavonoids
Who cannot join
- BMI >32 kg/m2
- Total serum cholesterol ≥ 8 mmol/l
- Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant
- Coronary artery disease
- Pregnancy or lactating
- Alcohol abuse as evaluated by medical history
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- Regular smoking/using nicotine products
- Diabetes mellitus
- Apple allergy
- Use of lipid lowering medications
- Regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction
- Any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject
- High consumption of vitamin products, herbal remedies or products containing flavonoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (FMD)in Volunteer Subjects
Effect of apple polyphenols on FMD.
Read the detailed description
The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.
- Conditions
- Borderline Hypertension
- Being tested
- Epicatechin, Microcrystalline cellulose
- Keywords
- FMD, epicatechin, apple polyphenol, borderline hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpicatechinDietary supplement
Microcrystalline celluloseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Epicatechin | Active comparator | The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods. Receives: Dietary Supplement: Epicatechin |
| Microcrystalline cellulose | Placebo comparator | The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods. Receives: Dietary Supplement: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial flow-mediated dilation test (FMD)
ultrasonography, FMDmax%
Measured: At first visits of both periods baseline FMD will be recorded followed by FMD recording 1.5 hours after first dose. After 4 weeks intervention, at last visits of both periods FMD will be recorded, last dose will be taken and FMD recorded 1.5 hours after.
Secondary outcomes (4)
Nitrate-mediated vasodilatation response (NMD)
ultrasonography, NMDmax%
Measured: At the first and last visits of both periods, approximately 10 minutes after FMD.
Circulating biomarkers of vascular function
depends on the biomarker
Measured: Once at the first visit of both periods and once at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
BP
Measured: Once at the first visit of both periods and once at the last visit of both periods. Blood pressure will be recorded twice prior to the morning dose.
Plasma epicatechin concentration
HPLC
Measured: At the first visit of both periods and at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
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 Borderline HypertensionStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Turku, 4Pharma Ltd.
- Responsible party
- Sponsor
- Investigators
- Kirsti Tiihonen, PhD, Study director, DaniscoOlli Raitakari, MD, Principal investigator, University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular MedicinePia Salo, MD, PhD, Principal investigator, University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular MedicineAnne Lithonius, Principal investigator, Clinical Research Services TurkuMika Scheinin, MD, PhD, Study chair, Clinical Research Services TurkuJari Turunen, MSc, Principal investigator, 4Pharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690676
- Sponsor's protocol ID
- Epi2012
- Status last verified
- Apr 2014
- First submitted
- 14 Sep 2012
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Saarenhovi M, Salo P, Scheinin M, Lehto J, Lovro Z, Tiihonen K, Lehtinen MJ, Junnila J, Hasselwander O, Tarpila A, Raitakari OT. The effect of an apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers on brachial artery flow-mediated vasodilatory function in volunteers with elevated blood pressure. Nutr J. 2017 Oct 27;16(1):73. doi: 10.1186/s12937-017-0291-0.
PubMed 29078780
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (FMD)in Volunteer Subjects
- ClinicalTrials.gov ID
- NCT01690676
- Acronym / sponsor ID
- Epi2012
- Conditions
- Borderline Hypertension
- Keywords
- FMD, epicatechin, apple polyphenol, borderline hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- University of Turku, 4Pharma Ltd.
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Sep 2012 (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.
Effect of apple polyphenols on FMD.
Detailed description
The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epicatechin | Active comparator | Dietary Supplement: EpicatechinThe subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods. |
| Microcrystalline cellulose | Placebo comparator | Dietary Supplement: Microcrystalline celluloseThe subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Borderline hypertension
- Otherwise healthy
- Aged 40-65 years (inclusive)
- Not consuming high amounts (over 20 mg daily) of flavonoids
Key exclusion criteria (13 listed)
- BMI >32 kg/m2
- Total serum cholesterol ≥ 8 mmol/l
- Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant
- Coronary artery disease
- Pregnancy or lactating
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 |
|---|---|---|
| Epicatechin | Dietary supplement | Epicatechin |
| Microcrystalline cellulose | Dietary supplement | Microcrystalline cellulose |
Primary outcome
Brachial flow-mediated dilation test (FMD)
Time frame: At first visits of both periods baseline FMD will be recorded followed by FMD recording 1.5 hours after first dose. After 4 weeks intervention, at last visits of both periods FMD will be recorded, last dose will be taken and FMD recorded 1.5 hours after.
ultrasonography, FMDmax%
4 secondary outcomes
Nitrate-mediated vasodilatation response (NMD)
Time frame: At the first and last visits of both periods, approximately 10 minutes after FMD.
Circulating biomarkers of vascular function
Time frame: Once at the first visit of both periods and once at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
BP
Time frame: Once at the first visit of both periods and once at the last visit of both periods. Blood pressure will be recorded twice prior to the morning dose.
Plasma epicatechin concentration
Time frame: At the first visit of both periods and at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
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 8 Apr 2014.
- Derived from this study: PubMed 29078780Saarenhovi M, Salo P, Scheinin M, Lehto J, Lovro Z, Tiihonen K, Lehtinen MJ, Junnila J, Hasselwander O, Tarpila A, Raitakari OT. The effect of an apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers on brachial artery flow-mediated vasodilatory function in volunteers with elevated blood pressure. Nutr J. 2017 Oct 27;16(1):73. doi: 10.1186/s12937-017-0291-0.
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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.
Kirsti Tiihonen, PhD study director
Danisco
Olli Raitakari, MD principal investigator
University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular Medicine
Pia Salo, MD, PhD principal investigator
University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epicatechin and Microcrystalline cellulose in people with Borderline Hypertension, run by Danisco at 1 site in Finland.
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 13 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 8 Apr 2014. 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 Finland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Brachial flow-mediated dilation test (FMD) (time frame: At first visits of both periods baseline FMD will be recorded followed by FMD recording 1.5 hours after first dose. After 4 weeks intervention, at last visits of both periods FMD will be recorded, last dose will be taken and FMD recorded 1.5 hours after.). 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 NCT01690676, 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 8 Apr 2014.