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Completed

NCT Number: NCT01358149

Trial of Cocoa-based Food in Children

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.

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Key information

Conditions

Motor Activity Behavior

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull York Medical School

Hull, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

cocoa-based food

Other

single intake of cocoa-based food

Primary outcomes

  1. Blood glucose concentration

    Time frame: Baseline will be fasting, and monitoring measures up to 7 hours after consumption

    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 outcomes

  1. Metabolic monitoring

    Time frame: measured over a 7-8 hours period

    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.

  2. physical monitoring

    Time frame: two hours and four hours after concumption

    Time Frame: the effects of one-off consumption will be measured two hours and four hours after consumption with 45 min physical activity sessions.

  3. mental monitoring

    Time frame: 3.3 hours after intake

    Time Frame: the effects of one-off consumption will be measured around 3.3 hours after intake. Baseline will be at fasting before intake.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Double Blind Controlled Trial of Cocoa-based Food in Children

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 23, 2011
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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