Influence of Sugar on the Bioavailability of Cocoa Flavanols

This study has been completed.
Sponsor:
Information provided by:
University of Reading
ClinicalTrials.gov Identifier:
NCT01292967
First received: February 9, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted

February 9, 2011
February 9, 2011
April 2008
June 2008   (final data collection date for primary outcome measure)
Impact of ingredients and matrices on flavanol absorption and metabolism. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
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 will be assessed by using HPLC with fluorescence detection
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Influence of Sugar on the Bioavailability of Cocoa Flavanols
The Influence of Maltitol on the Absorption and Metabolism of Flavanols From Chocolate

The primary propose of this study is to determine the impact of ingredients and matrices on flavanol absorption and metabolism.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Dietary Supplement: Low flavanol chocolate
    48 mg of total flavanols from cocoa
  • Dietary Supplement: High-flavanol with sugar
    high-flavanol containing 251 mg cocoa flavanols
  • Dietary Supplement: High flavanol Maltitol
    high-flavanol containing 266 mg cocoa flavanols
  • Placebo Comparator: Low flavanol
    Low-flavanol chocolate contained 48 mg of cocoa flavanols. macro- and micro-nutrient matched with active comparator
    Intervention: Dietary Supplement: Low flavanol chocolate
  • Active Comparator: High-flavanol with sugar
    High-flavanol chocolate made with added sugar containing 251 mg of cocoa flavanols
    Intervention: Dietary Supplement: High-flavanol with sugar
  • Active Comparator: High flavanol Maltitol
    High-flavanol chocolate made with the sugar substitute maltitol containing 266 mg cocoa flavanols
    Intervention: Dietary Supplement: High flavanol Maltitol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • a signed consent form
  • age of 18-50 years inclusive

Exclusion Criteria:

  • did not suffer from any form of disease, including liver disease, diabetes mellitus or a myocardial infarction
  • not on medications for the treatment of hypertension, elevated lipids or diabetes (type I and II).
  • did not suffered gall bladder problems or abnormalities of fat metabolism
  • weight reducing dietary regimen or taking any dietary supplements, including dietary fatty acids
  • did not consume more than 15 units (120g) of alcohol per week
  • did not have sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten.
  • Vegetarians and vegans
  • taken antibiotics in the last 8 weeks
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01292967
UReading-2010_03
Yes
Dr Jeremy P E Spencer, University of Reading
University of Reading
Not Provided
Principal Investigator: Jeremy Spencer, PhD University of Reading
University of Reading
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP