Influence of Sugar on the Bioavailability of Cocoa Flavanols

February 9, 2011 updated by: University of Reading

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AP
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of ingredients and matrices on flavanol absorption and metabolism.
Time Frame: 4 hours
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
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Investigators

  • Principal Investigator: Jeremy Spencer, PhD, University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 10, 2011

Study Record Updates

Last Update Posted (Estimate)

February 10, 2011

Last Update Submitted That Met QC Criteria

February 9, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UReading-2010_03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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