Influence of Sugar on the Bioavailability of Cocoa Flavanols

NCT ID: NCT01292967

Last Updated: 2011-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low flavanol

Low-flavanol chocolate contained 48 mg of cocoa flavanols. macro- and micro-nutrient matched with active comparator

Group Type PLACEBO_COMPARATOR

Low flavanol chocolate

Intervention Type DIETARY_SUPPLEMENT

48 mg of total flavanols from cocoa

High-flavanol with sugar

High-flavanol chocolate made with added sugar containing 251 mg of cocoa flavanols

Group Type ACTIVE_COMPARATOR

High-flavanol with sugar

Intervention Type DIETARY_SUPPLEMENT

high-flavanol containing 251 mg cocoa flavanols

High flavanol Maltitol

High-flavanol chocolate made with the sugar substitute maltitol containing 266 mg cocoa flavanols

Group Type ACTIVE_COMPARATOR

High flavanol Maltitol

Intervention Type DIETARY_SUPPLEMENT

high-flavanol containing 266 mg cocoa flavanols

Interventions

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Low flavanol chocolate

48 mg of total flavanols from cocoa

Intervention Type DIETARY_SUPPLEMENT

High-flavanol with sugar

high-flavanol containing 251 mg cocoa flavanols

Intervention Type DIETARY_SUPPLEMENT

High flavanol Maltitol

high-flavanol containing 266 mg cocoa flavanols

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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University of Reading

Principal Investigators

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Jeremy Spencer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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University of Reading

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UReading-2010_03

Identifier Type: -

Identifier Source: org_study_id

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