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CompletedNCT01358149Updated Oct 30, 2013

Trial of Cocoa-based Food in Children

An interventional study of cocoa-based food and cocoa-based food in Motor Activity, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in United Kingdom. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-30.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Motor Activity
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Placebo comparator
    placebo

    cocoa-based food 1

    Other: cocoa-based food

  • Active comparator
    Treatment 1

    cocoa-based food 2

    Other: cocoa-based food

Interventions

  • Othercocoa-based food

    single intake of cocoa-based food

  • Othercocoa-based food

    Single intake of cocoa-based food

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

    Time frame: measured over a 7-8 hours period

  2. 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.

    Time frame: two hours and four hours after concumption

  3. 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.

    Time frame: 3.3 hours after intake

07

Study locations

1 site
  • Hull York Medical School
    Hull, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01358149
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
May 23, 2011
Start date
May 2011
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Oct 30, 2013

Study contacts

Stephen Atkin, Prof. Dr.
principal investigator · Hull University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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