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

This study has been completed.
Sponsor:
Collaborators:
University of Turku
4Pharma Ltd.
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01690676
First received: September 14, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

Effect of apple polyphenols on FMD.


Condition Intervention Phase
Borderline Hypertension
Dietary Supplement: Epicatechin
Dietary Supplement: Microcrystalline cellulose
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Danisco:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    ultrasonography, FMDmax%


Secondary Outcome Measures:
  • Nitrate-mediated vasodilatation response (NMD) [ Time Frame: At the first and last visits of both periods, approximately 10 minutes after FMD. ] [ Designated as safety issue: No ]
    ultrasonography, NMDmax%

  • 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 ] [ Designated as safety issue: No ]
    depends on the biomarker

  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    HPLC


Enrollment: 57
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epicatechin
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.
Dietary Supplement: Epicatechin
Placebo Comparator: Microcrystalline cellulose
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.
Dietary Supplement: Microcrystalline cellulose

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690676

Locations
Finland
University of Turku
Turku, Finland
Sponsors and Collaborators
Danisco
University of Turku
4Pharma Ltd.
Investigators
Study Director: Kirsti Tiihonen, PhD Danisco
Principal Investigator: Olli Raitakari, MD University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular Medicine
Principal Investigator: Pia Salo, MD, PhD University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular Medicine
Principal Investigator: Anne Lithonius Clinical Research Services Turku
Study Chair: Mika Scheinin, MD, PhD Clinical Research Services Turku
Principal Investigator: Jari Turunen, MSc 4Pharma Ltd.
  More Information

No publications provided

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01690676     History of Changes
Other Study ID Numbers: Epi2012
Study First Received: September 14, 2012
Last Updated: April 7, 2014
Health Authority: Finland: Hospital District of Southwest Finland Ethics Committee

Keywords provided by Danisco:
FMD
epicatechin
apple polyphenol
borderline hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014