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Trial of Cocoa-based Food in Children

Double Blind Controlled Trial of Cocoa-based Food in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01358149
Enrollment
25
Registered
2011-05-23
Start date
2011-05-31
Completion date
2011-09-30
Last updated
2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Activity

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.

Interventions

OTHERcocoa-based food

single intake of cocoa-based food

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Blood glucose concentrationBaseline will be fasting, and monitoring measures up to 7 hours after consumptionTime 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

MeasureTime frameDescription
Metabolic monitoringmeasured over a 7-8 hours periodTime 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 monitoringtwo hours and four hours after concumptionTime Frame: the effects of one-off consumption will be measured two hours and four hours after consumption with 45 min physical activity sessions.
mental monitoring3.3 hours after intakeTime Frame: the effects of one-off consumption will be measured around 3.3 hours after intake. Baseline will be at fasting before intake.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026