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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

September 14, 2012
April 7, 2014
August 2012
May 2013   (final data collection date for 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. ] [ Designated as safety issue: No ]
ultrasonography, FMDmax%
Same as current
Complete list of historical versions of study NCT01690676 on ClinicalTrials.gov Archive Site
  • 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
  • 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: Baseline, at the first visit of both periods and at the last visit of both periods. ] [ 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
Not Provided
Not Provided
 
Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Borderline Hypertension
  • Dietary Supplement: Epicatechin
  • Dietary Supplement: Microcrystalline cellulose
  • 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.
    Intervention: 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.
    Intervention: Dietary Supplement: Microcrystalline cellulose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01690676
Epi2012
No
Danisco
Danisco
  • University of Turku
  • 4Pharma Ltd.
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.
Danisco
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP