Trial of Cocoa-based Food in Children

Nestlé

Status: Completed

Conditions: Motor Activity

Treatments: Other: cocoa-based food

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358149

10.23.NRC

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

cocoa-based food 1

Treatment:

Other: cocoa-based food

Other: cocoa-based food

Treatment 1

Active Comparator group

Description:

cocoa-based food 2

Treatment:

Other: cocoa-based food

Other: cocoa-based food