Trial of Cocoa-based Food in Children

Motor Activity Clinical Trial

Official title:

Double Blind Controlled Trial of Cocoa-based Food in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358149
• Other study ID #: 10.23.NRC
• Status: Completed
• Phase: N/A
• First received: May 13, 2011
• Last updated: October 29, 2013
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Food Standards Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Motor Activity

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Hull York Medical School	Hull

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No