Pharmacokinetics and Pharmacodynamics of Anthocyanins | NCT03650140 | Trialant

Pharmacokinetics and Pharmacodynamics of Anthocyanins | NCT03650140 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tart cherry concentrate 60 mL	Active Comparator	Subjects will receive a single oral dose of 60 mL tart cherry concentrate. After a 2 week wash-out subjects will cross over into the 120 mL dose group.	Dietary Supplement: Tart cherry extract 60 mL Dietary Supplement: Tart cherry extract 120 mL
Tart cherry concentrate 120 mL	Active Comparator	Subjects will receive a single oral dose of 120 mL tart cherry concentrate. After a 2 week wash-out subjects will cross over into the 60 mL dose group.	Dietary Supplement: Tart cherry extract 60 mL Dietary Supplement: Tart cherry extract 120 mL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tart cherry extract 60 mL	Dietary Supplement	Subjects will receive a single 60 mL oral dose of tart cherry extract.	Tart cherry concentrate 120 mL Tart cherry concentrate 60 mL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Highly sensitive C-reactive protein (hs-CRP)	Reduction in hs-CRP	Maximal change in hs-CRP from baseline through study completion (during the 12 hours after a dose)

Secondary Outcomes

Measure	Description	Time Frame
Area under the curve (AUC)	The area under the plasma anthocyanin concentration-time curve	Through study completion (during the 12 hours after a dose)
Change in inflammatory marker expression

Contacts/Locations Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jun 23, 2021	Jan 5, 2023	ICF_000.pdf

Condition Browse Module