NCT02149238

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. However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2011

Typical duration 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

February 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

3.8 years

First QC Date

May 22, 2014

Last Update Submit

December 19, 2014

Conditions

Cardiovascular Diseases

Keywords

flavanolscardiovascular effectsnutrition-nutrition interaction

Outcome Measures

Primary Outcomes (2)

  • Endothelial function

    Flow mediated dilatation (FMD)

    2 hours

  • Plasma flavanol metabolites

    Measured by HPLC

    2 hours

Secondary Outcomes (3)

  • Pulse wave velocity

    2 hours

  • Ambulatory blood pressure

    2 hours

  • Circulation angiogenetic cells

    2 hours

Study Arms (3)

flavanol rich drink intervention

ACTIVE COMPARATOR

flavanol rich drink

Dietary Supplement: flavanol

methylxanthine rich drink intervention

ACTIVE COMPARATOR

methylxanthine rich drink

Dietary Supplement: methylxanthine

flavanol + methylxanthine rich drink intervention

ACTIVE COMPARATOR

flavanol + methylxanthine rich drink

Dietary Supplement: flavanol + methylxanthine

Interventions

flavanolDIETARY_SUPPLEMENT
flavanol rich drink intervention
methylxanthineDIETARY_SUPPLEMENT
methylxanthine rich drink intervention
flavanol + methylxanthineDIETARY_SUPPLEMENT
flavanol + methylxanthine rich drink intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects
  • \>18 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

Related Publications (1)

  • Sansone R, Ottaviani JI, Rodriguez-Mateos A, Heinen Y, Noske D, Spencer JP, Crozier A, Merx MW, Kelm M, Schroeter H, Heiss C. Methylxanthines enhance the effects of cocoa flavanols on cardiovascular function: randomized, double-masked controlled studies. Am J Clin Nutr. 2017 Feb;105(2):352-360. doi: 10.3945/ajcn.116.140046. Epub 2016 Dec 21.

    PMID: 28003203DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

methylxanthine

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
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 29, 2014

Study Start

February 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

DE(1)