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Trial of Cocoa-based Food in Children

NCT ID: NCT01358149

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Motor Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

cocoa-based food 1

Group Type PLACEBO_COMPARATOR

cocoa-based food

Intervention Type OTHER

single intake of cocoa-based food

Treatment 1

cocoa-based food 2

Group Type ACTIVE_COMPARATOR

cocoa-based food

Intervention Type OTHER

Single intake of cocoa-based food

Interventions

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cocoa-based food

single intake of cocoa-based food

Intervention Type OTHER

cocoa-based food

Single intake of cocoa-based food

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Atkin, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hull University

Locations

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Hull York Medical School

Hull, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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10.23.NRC

Identifier Type: -

Identifier Source: org_study_id