Influence of Sugar on the Bioavailability of Cocoa Flavanols

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Low flavanol chocolate
* Dietary Supplement: High-flavanol with sugar
* Dietary Supplement: High flavanol Maltitol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Low flavanol<br>Low-flavanol chocolate contained 48 mg of cocoa flavanols. macro- and micro-nutrient matched with active comparator | Dietary Supplement: Low flavanol chocolate<br>* 48 mg of total flavanols from cocoa<br>|
| Active Comparator: High-flavanol with sugar<br>High-flavanol chocolate made with added sugar containing 251 mg of cocoa flavanols | Dietary Supplement: High-flavanol with sugar<br>* high-flavanol containing 251 mg cocoa flavanols<br>|
| Active Comparator: High flavanol Maltitol<br>High-flavanol chocolate made with the sugar substitute maltitol containing 266 mg cocoa flavanols | Dietary Supplement: High flavanol Maltitol<br>* high-flavanol containing 266 mg cocoa flavanols<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of ingredients and matrices on flavanol absorption and metabolism. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flavanol, cocoa, maltitol, absorption, metabolism, chocolate, food matrix, bioavailability