Trial of Cocoa-based Food in Children

NCT01358149 | Completed DMC

• 1 other identifier: 10.23.NRC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Metabolic monitoring

  measured over a 7-8 hours period

• physical monitoring

  two hours and four hours after concumption

• mental monitoring

  3.3 hours after intake

Study Arms (2)

placebo

PLACEBO COMPARATOR

cocoa-based food 1

Other: cocoa-based food

Treatment 1

ACTIVE COMPARATOR

cocoa-based food 2

Other: cocoa-based food

Interventions

cocoa-based food OTHER

single intake of cocoa-based food

placebo

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Hull York Medical School

Hull, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Stephen Atkin, Prof. Dr.

  Hull University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 23, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

GB (1)