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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014