Trial of Cocoa-based Food in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01358149
First received: May 13, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Motor Activity
Other: cocoa-based food

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Controlled Trial of Cocoa-based Food in Children

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Blood glucose concentration [ Time Frame: Baseline will be fasting, and monitoring measures up to 7 hours after consumption ] [ Designated as safety issue: No ]
    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:
  • Metabolic monitoring [ Time Frame: measured over a 7-8 hours period ] [ Designated as safety issue: No ]
    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.

  • physical monitoring [ Time Frame: two hours and four hours after concumption ] [ Designated as safety issue: No ]
    Time Frame: the effects of one-off consumption will be measured two hours and four hours after consumption with 45 min physical activity sessions.

  • mental monitoring [ Time Frame: 3.3 hours after intake ] [ Designated as safety issue: No ]
    Time Frame: the effects of one-off consumption will be measured around 3.3 hours after intake. Baseline will be at fasting before intake.


Enrollment: 25
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
cocoa-based food 1
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

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358149

Locations
United Kingdom
Hull York Medical School
Hull, United Kingdom
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Stephen Atkin, Prof. Dr. Hull University
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01358149     History of Changes
Other Study ID Numbers: 10.23.NRC
Study First Received: May 13, 2011
Last Updated: October 29, 2013
Health Authority: United Kingdom: Food Standards Agency

ClinicalTrials.gov processed this record on April 14, 2014