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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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22741
Enrollment
6
Registered
2011-04-04
Start date
2011-05-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cocoa and chocolate products have generated significant interest due to their association with various health-protective and therapeutic activities. Cocoa and chocolate are rich sources of flavan-3-ols, which are present in monomeric and polymeric forms.

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 n

Sponsors

ProDigest BVBA Technologiepark 3, 9052 Zwijnaarde, België Tel: +32/ 9 264 59 78
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults between 20 and 45 years old; 2. Non-smoking individuals; 3. Capable and willing to sign the Informed Consent Form at voluntary basis; 4. Considered healthy based on their medical history and physical examination; 5. Female volunteers do not intend to become pregnant prior to or during the study and using adequate contraception.

Exclusion criteria

Exclusion criteria: 1. Clinically significant abnormal liver biochemistry; 2. Clinically significant abnormal serum creatinin; 3. Abnormal body mass index; 4. Use of concomitant medications or supplements.

Design outcomes

Primary

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

Secondary

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

Contacts

Public ContactF. Vanmolkot

P. Debyelaan 25

floris.vanmolkot@mumc.nl+31 (0)43 3872640

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)