Trial of Cocoa-based Food in Children

Not Applicable

Completed

• Conditions: Motor Activity
• Interventions: Other: cocoa-based food

• Registration Number: NCT01358149
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 1	cocoa-based food	cocoa-based food 2
placebo	cocoa-based food	cocoa-based food 1

Primary Outcome Measures

Name	Time	Method
Blood glucose concentration	Baseline will be fasting, and monitoring measures up to 7 hours after consumption	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.

Secondary Outcome Measures

Name	Time	Method
Metabolic monitoring	measured over a 7-8 hours period	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.
mental monitoring	3.3 hours after intake	Time Frame: the effects of one-off consumption will be measured around 3.3 hours after intake. Baseline will be at fasting before intake.
physical monitoring	two hours and four hours after concumption	Time Frame: the effects of one-off consumption will be measured two hours and four hours after consumption with 45 min physical activity sessions.

Trial Locations

Locations (1)

Hull York Medical School; 🇬🇧 Hull, United Kingdom