Trial of Cocoa-based Food in Children

Study Overview
=================
Brief Summary
-----------------
Today, there is an important lack of knowledge on child metabolism and the effects of phytochemical-rich foods, which includes fruits and vegetables and plant-derived foods. Here, the investigators will monitor the metabolism of children using minimally invasive techniques at rest, and with physical/mental activities and assess the changes associated with the intake of cocoa-based food.

Official Title
-----------------
Double Blind Controlled Trial of Cocoa-based Food in Children

Conditions
-----------------
Motor Activity

Intervention / Treatment
-----------------
* Other: cocoa-based food
* Other: cocoa-based food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects must comply with all the following inclusion criteria: Healthy and physically active, and no diabetes or metabolism related disorders in their first degree relatives (as determined by medical and activity questionnaire) Caucasian, with English as a first language and an adequate standard of literacy. BMI adjusted for age and gender which falls between the 9th and 91st as shown in the Child Growth Foundation BMI growth charts 8-13 years of age Having obtained his/her informed assent Having obtained his/her legal representative's informed consent Willing to allow their family doctor (GP) to be informed about their participation in this study Exclusion Criteria: Subjects representing one or more of the following criteria are excluded from participation in the study. Post-pubertal Taking any medication Smoker Undergoing medical treatment or investigations Body mass index > 24 Suffer from chronic diseases (with regular intake of drugs, medical history) Vegetarians Vaccination in the last 4 months Any know food allergies or intolerance Pregnancy Special diet or weight loss program (e.g. Atkins diet) Acute illness Fever, cold, flu Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts).

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>cocoa-based food 1 | Other: cocoa-based food<br>* single intake of cocoa-based food<br>|
| Active Comparator: Treatment 1<br>cocoa-based food 2 | Other: cocoa-based food<br>* Single intake of cocoa-based food<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose concentration | Time Frame: the effects of one-off consumption will be measured over a 7-8 hours period. Baseline will be fasting, and monitoring measures up to 7 hours after consumption. The subjects will be on controlled diet the day prior to the visit. | Baseline will be fasting, and monitoring measures up to 7 hours after consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic monitoring | Time Frame: the effects of one-off consumption will be measured over a 7-8 hours period. Baseline will be fasting, and monitoring measures up to 7 hours after consumption. The subjects will be on controlled diet the day prior to the visit. | measured over a 7-8 hours period | 
| physical monitoring | Time Frame: the effects of one-off consumption will be measured two hours and four hours after consumption with 45 min physical activity sessions. | two hours and four hours after concumption | 
| mental monitoring | Time Frame: the effects of one-off consumption will be measured around 3.3 hours after intake. Baseline will be at fasting before intake. | 3.3 hours after intake |