MedDataX Logo

Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

NCT ID: NCT02149238

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

flavanols cardiovascular effects nutrition-nutrition interaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

flavanol rich drink intervention

flavanol rich drink

Group Type ACTIVE_COMPARATOR

flavanol

Intervention Type DIETARY_SUPPLEMENT

methylxanthine rich drink intervention

methylxanthine rich drink

Group Type ACTIVE_COMPARATOR

methylxanthine

Intervention Type DIETARY_SUPPLEMENT

flavanol + methylxanthine rich drink intervention

flavanol + methylxanthine rich drink

Group Type ACTIVE_COMPARATOR

flavanol + methylxanthine

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

flavanol

Intervention Type DIETARY_SUPPLEMENT

methylxanthine

Intervention Type DIETARY_SUPPLEMENT

flavanol + methylxanthine

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy male subjects
* \>18 years

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Klinik für Kardiologie, Pneumologie und Angiologie

Klinik für Kardiologie, Pneumologie und Angiologie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Heiss, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine

Malte Kelm, MD

Role: STUDY_CHAIR

Division of Cardiology, Pulmonology and Vascular Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Cardiology, Pulmonology and Vascular Medicine

Düsseldorf, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28003203 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

New Drink

Identifier Type: -

Identifier Source: org_study_id