Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT01292967
Status:
COMPLETED
Last Update Posted:
2011-02-10
First Post:
2011-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Sugar on the Bioavailability of Cocoa Flavanols
Sponsor:
University of Reading
Organization:
Study Overview
Official Title:
The Influence of Maltitol on the Absorption and Metabolism of Flavanols From Chocolate
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary propose of this study is to determine the impact of ingredients and matrices on flavanol absorption and metabolism.
Detailed Description:
The investigators have conducted a randomized, triple-blind, cross-over study in 15 healthy human volunteers to investigate the absorption and metabolism of cocoa flavanols from a high-flavanol chocolate made with added sugar and a high-flavanol chocolate containing the sugar substitute maltitol; a nutrient-matched low flavanol control product was also fed. All products were matched for macro-nutrients, as well as for alkaloids (theobromine and caffeine), and were similar in taste and appearance. Both high-flavanol products contained \~259 mg cocoa flavanols, whilst the low-flavanol chocolate contained 48 mg of cocoa flavanols. On each study day, subjects were cannulated and baseline blood samples were collected prior to consumption of any of the test chocolates. Additional blood samples were collected at 1, 2 and 4 hours and plasma levels of flavanols were assessed using HPLC with fluorescence detection. All test products were well-tolerated by study participants.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: