Trial of Cocoa-based Food in Children

Double Blind Controlled Trial of Cocoa-based Food in Children

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.

Study Overview

• Status: Completed
• Conditions: Motor Activity
• Intervention / Treatment: Other: cocoa-based food; Other: cocoa-based food

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hull, United Kingdom
    • Hull York Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; cocoa-based food 1	Other: cocoa-based food; single intake of cocoa-based food; Other: cocoa-based food; Single intake of cocoa-based food
Active Comparator: Treatment 1; cocoa-based food 2	Other: cocoa-based food; single intake of cocoa-based food; Other: cocoa-based food; Single intake of cocoa-based food

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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Stephen Atkin, Prof. Dr., Hull University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: May 13, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 10.23.NRC