NCT02147223

Brief Summary

Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

May 22, 2014

Last Update Submit

April 15, 2015

Conditions

Cardiovascular Diseases

Keywords

flavanolssex-related cardiovascular effects

Outcome Measures

Primary Outcomes (1)

  • Absolute change of Flow-mediated Vasodilation (FMD)

    2 hours

Secondary Outcomes (5)

  • Pulse wave velocity

    2 hours

  • Augmentation index

    2 hours

  • Ambulatory blood pressure

    2 hours

  • Plasma flavanol metabolites

    2 hours

  • laboratory safety parameters

    2 hours

Study Arms (4)

Flavanol rich product A

ACTIVE COMPARATOR

250 mg flavanols

Dietary Supplement: Flavanol rich interventionDietary Supplement: Flavanol free intervention

Flavanol rich product B

ACTIVE COMPARATOR

500 mg flavanols

Dietary Supplement: Flavanol rich interventionDietary Supplement: Flavanol free intervention

Flavanol rich product C

ACTIVE COMPARATOR

750 mg flavanols

Dietary Supplement: Flavanol rich interventionDietary Supplement: Flavanol free intervention

Flavanol free product

PLACEBO COMPARATOR

flavanol free

Dietary Supplement: Flavanol rich intervention

Interventions

Flavanol rich interventionDIETARY_SUPPLEMENT

Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)

Flavanol free productFlavanol rich product AFlavanol rich product BFlavanol rich product C
Flavanol free interventionDIETARY_SUPPLEMENT

Calorically, micro- and macronutrient matched control product free of flavanols

Flavanol rich product AFlavanol rich product BFlavanol rich product C

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy post-menopausal femal subjects (\>50 years)
  • healthy male subjects (\>50 years)

You may not qualify if:

  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • CRP \> 1 mg/dl
  • malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonology and Vascular Medicine

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Christian Heiss, MD

    Division of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

  • Ana Rodriguez Mateos, PhD

    Division of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

  • Malte Kelm, MD

    Division of Cardiology, Pulmonology and Vascular Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Klinik für Kardiologie, Pneumologie und Angiologie

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 26, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

DE(1)