Influence of Sugar on the Bioavailability of Cocoa Flavanols

Sponsor

University of Reading (Other)

Overall Status

Completed

CT.gov ID

NCT01292967

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Low flavanol chocolate Dietary Supplement: High-flavanol with sugar Dietary Supplement: High flavanol Maltitol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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