NCT01639781

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. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 cardiovascular-diseases

Timeline
Completed

Started Nov 2011

Typical duration for phase_1 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, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

June 6, 2012

Last Update Submit

December 14, 2014

Conditions

Cardiovascular Diseases

Keywords

flavanolsage related cardiovascular effects

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    Flow mediated dilatation (FMD)

    change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14

Secondary Outcomes (8)

  • Plasma flavanol metabolites

    analysis of metabolites between first treatment at day 0 and after last treatment at day 14

  • Ambulatory blood pressure

    blood pressure at day 0 and at day 14

  • Pulse wave velocity

    14 days

  • Microvascular function

    14 days

  • Augmentation index

    14 days

  • +3 more secondary outcomes

Study Arms (2)

flavanol rich intervention

ACTIVE COMPARATOR

flavanol rich drink

Dietary Supplement: Flavanol rich intervention

flavanol free intervention

PLACEBO COMPARATOR

flavanol free drink

Dietary Supplement: Flavanol free control

Interventions

Flavanol rich interventionDIETARY_SUPPLEMENT

Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks

flavanol rich intervention
Flavanol free controlDIETARY_SUPPLEMENT

Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks

flavanol free intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male participants between 18-35 years
  • healthy male participants between 50-80 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, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

  • Heiss C, Sansone R, Karimi H, Krabbe M, Schuler D, Rodriguez-Mateos A, Kraemer T, Cortese-Krott MM, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M; FLAVIOLA Consortium, European Union 7th Framework Program. Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial. Age (Dordr). 2015 Jun;37(3):9794. doi: 10.1007/s11357-015-9794-9. Epub 2015 May 27.

    PMID: 26013912DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Christian Heiss, MD

    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
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Klinik für Kardiologie, Pneumologie und Angiologie

Study Record Dates

First Submitted

June 6, 2012

First Posted

July 13, 2012

Study Start

November 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

DE(1)