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: January 27, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 13, 2011

Last Updated Date

January 27, 2012

Start Date ^ICMJE

May 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01358149 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial of Cocoa-based Food in Children

Official Title ^ICMJE

Double Blind Controlled Trial of Cocoa-based Food in Children

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Motor Activity

Intervention ^ICMJE

Other: cocoa-based food
single intake of cocoa-based food
Other: cocoa-based food
Single intake of cocoa-based food

Study Arm (s)

Placebo Comparator: placebo
cocoa-based food 1

Intervention: Other: cocoa-based food
Active Comparator: Treatment 1
cocoa-based food 2

Intervention: Other: cocoa-based food

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

8 Years to 13 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01358149

Other Study ID Numbers ^ICMJE

10.23.NRC

Has Data Monitoring Committee

Yes

Responsible Party

Nestlé

Study Sponsor ^ICMJE

Nestlé

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stephen Atkin, Prof. Dr.

Hull University

Information Provided By

Nestlé

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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