Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function

Borderline Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690676
• Other study ID #: Epi2012
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2012
• Last updated: April 7, 2014
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: April 2014
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Hospital District of Southwest Finland Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Effect of apple polyphenols on FMD.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Borderline hypertension

• Otherwise healthy

• Aged 40-65 years (inclusive)

• Not consuming high amounts (over 20 mg daily) of flavonoids

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Borderline Hypertension
• Hypertension

Intervention

Dietary Supplement:
• Epicatechin

• Microcrystalline cellulose

Locations

Country	Name	City	State
Finland	University of Turku	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Danisco	4Pharma Ltd., University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial flow-mediated dilation test (FMD)	ultrasonography, FMDmax%	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.	No
Secondary	Nitrate-mediated vasodilatation response (NMD)	ultrasonography, NMDmax%	At the first and last visits of both periods, approximately 10 minutes after FMD.	No
Secondary	Circulating biomarkers of vascular function	depends on the biomarker	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	No
Secondary	BP		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.	No
Secondary	Plasma epicatechin concentration	HPLC	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	No