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Pharmacokinetic study to assess the bioavailability of the cocoa flavanols catechin and epicatechin from different matrices.

Pharmacokinetic study to assess the bioavailability of the cocoa flavanols catechin and epicatechin from different matrices. - Bioavailabilty of cocoa flavanols from different matrces

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35796
Enrollment
10
Registered
2011-05-20
Start date
2011-06-15
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular disease

Interventions

Five single doses of a cocoa products in randomised order with a minimal 5-day interval. Four of those cocoa products contain a high level of flavenols and are commercially available. One product is

Sponsors

Callebaut NV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Adults between 20 and 45 years old -Non*smoking individuals -Capable and willing to sign the Informed Consent Form at voluntary basis -Considered healthy based on their medical history as questioned by the investigator during an interview and a general physical examination by the investigator -Female volunteers do not intend to become pregnant prior to or during the study and using adequate contraception

Exclusion criteria

Exclusion criteria: -Clinically significant abnormal liver biochemistry -Clinically significant abnormal serum creatinin -Abnormal body mass index -Use of concomitant medications or supplements -Blood donation during the last 4 weeks prior to the first dosing till 4 weeks after the last dosing

Design outcomes

Primary

MeasureTime frame
Area under the blood concetration - time curve (AUC).

Secondary

MeasureTime frame
Maximal blood concentration (Cmax) and time to maximal blood concentration (Tmax).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)