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

NCT01690676 | Completed Phase 2

• 1 other identifier: Epi2012
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of apple polyphenols on FMD.

Conditions

Borderline Hypertension

Keywords

FMD; epicatechin; apple polyphenol; borderline hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Nitrate-mediated vasodilatation response (NMD)

  At the first and last visits of both periods, approximately 10 minutes after FMD.

• Circulating biomarkers of vascular function

  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

  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

  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

Study Arms (2)

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.

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.

Dietary Supplement: Microcrystalline cellulose

Interventions

Epicatechin DIETARY_SUPPLEMENT

Epicatechin

Microcrystalline cellulose DIETARY_SUPPLEMENT

Microcrystalline cellulose

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Borderline hypertension
• Otherwise healthy
• Aged 40-65 years (inclusive)
• Not consuming high amounts (over 20 mg daily) of flavonoids

You may not qualify if:

• 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

Sponsors & Collaborators

• Danisco: lead
• University of Turku: collaborator
• 4Pharma Ltd.: collaborator

Study Sites (1)

University of Turku

Turku, Finland

Location

Related Publications (1)

• 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.

  PMID: 29078780 DERIVED

MeSH Terms

Interventions

Catechin; microcrystalline cellulose

Intervention Hierarchy (Ancestors)

Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonoids; Chromones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kirsti Tiihonen, PhD

  Danisco

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• Mika Scheinin, MD, PhD

  Clinical Research Services Turku

  STUDY CHAIR

• Jari Turunen, MSc

  4Pharma Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 24, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

FI (1)