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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
  Purpose

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


Condition Intervention
Healthy
 Dietary Supplement: Low flavanol chocolate
Dietary Supplement: High-flavanol with sugar
Dietary Supplement: High flavanol Maltitol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Influence of Maltitol on the Absorption and Metabolism of Flavanols From Chocolate

Resource links provided by NLM:

Drug Information available for: Maltitol
U.S. FDA Resources

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • 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


Enrollment: 15
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Low flavanol
Low-flavanol chocolate contained 48 mg of cocoa flavanols. macro- and micro-nutrient matched with active comparator
 Dietary Supplement: Low flavanol chocolate
48 mg of total flavanols from cocoa
Active Comparator: High-flavanol with sugar
High-flavanol chocolate made with added sugar containing 251 mg of cocoa flavanols
 Dietary Supplement: High-flavanol with sugar
high-flavanol containing 251 mg cocoa flavanols
Active Comparator: High flavanol Maltitol
High-flavanol chocolate made with the sugar substitute maltitol containing 266 mg cocoa flavanols
 Dietary Supplement: High flavanol Maltitol
high-flavanol containing 266 mg cocoa flavanols

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292967

Locations
United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Investigators
Principal Investigator: Jeremy Spencer, PhD University of Reading
  More Information

No publications provided

Responsible Party: Dr Jeremy P E Spencer, University of Reading
ClinicalTrials.gov Identifier: NCT01292967     History of Changes
Other Study ID Numbers: UReading-2010_03
Study First Received: February 9, 2011
Last Updated: February 9, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Reading:
Flavanol
cocoa
maltitol
absorption
 metabolism
chocolate
food matrix
bioavailability

ClinicalTrials.gov processed this record on May 21, 2013