Influence of Sugar on the Bioavailability of Cocoa Flavanols

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Low flavanol chocolate; Dietary Supplement: High-flavanol with sugar; Dietary Supplement: High flavanol Maltitol

• Registration Number: NCT01292967
• Lead Sponsor: University of Reading

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 Timeline

• Study Start: 2008-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2010-12
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Last Update Submitted: 2011-02-09
• Study First Posted: 2011-02-10
• Last Update Posted: 2011-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low flavanol	Low flavanol chocolate	Low-flavanol chocolate contained 48 mg of cocoa flavanols. macro- and micro-nutrient matched with active comparator
High-flavanol with sugar	High-flavanol with sugar	High-flavanol chocolate made with added sugar containing 251 mg of cocoa flavanols
High flavanol Maltitol	High flavanol Maltitol	High-flavanol chocolate made with the sugar substitute maltitol containing 266 mg cocoa flavanols

Primary Outcome Measures

Name	Time	Method
Impact of ingredients and matrices on flavanol absorption and metabolism.	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

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, Berkshire, United Kingdom