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Completed

NCT Number: NCT01292967

Influence of Sugar on the Bioavailability of Cocoa Flavanols

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

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low flavanol chocolate

Dietary Supplement

48 mg of total flavanols from cocoa

High-flavanol with sugar

Dietary Supplement

high-flavanol containing 251 mg cocoa flavanols

High flavanol Maltitol

Dietary Supplement

high-flavanol containing 266 mg cocoa flavanols

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

The Influence of Maltitol on the Absorption and Metabolism of Flavanols From Chocolate

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 10, 2011
Registry last updated
Feb 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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