Motor ActivityNCT01358149
Trial of Cocoa-based Food in Children
A study testing cocoa-based food in people with Motor Activity, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- cocoa-based food
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Controlled 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.
- Conditions
- Motor Activity
- Being tested
- cocoa-based food
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocoa-based foodOther
single intake of cocoa-based food
cocoa-based foodOther
Single intake of cocoa-based food
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | cocoa-based food 1 Receives: Other: cocoa-based food |
| Treatment 1 | Active comparator | cocoa-based food 2 Receives: Other: cocoa-based food |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline will be fasting, and monitoring measures up to 7 hours after consumption
Secondary outcomes (3)
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: measured over a 7-8 hours period
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.
Measured: two hours and four hours after concumption
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.
Measured: 3.3 hours after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Atkin, Prof. Dr., Principal investigator, Hull University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358149
- Sponsor's protocol ID
- 10.23.NRC
- Status last verified
- Oct 2013
- First submitted
- 13 May 2011
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Controlled Trial of Cocoa-based Food in Children
- ClinicalTrials.gov ID
- NCT01358149
- Acronym / sponsor ID
- 10.23.NRC
- Conditions
- Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: cocoa-based foodcocoa-based food 1 |
| Treatment 1 | Active comparator | Other: cocoa-based foodcocoa-based food 2 |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cocoa-based foodsingle intake of cocoa-based food | Other | placebo |
| cocoa-based foodSingle intake of cocoa-based food | Other | Treatment 1 |
Primary outcome
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.
3 secondary outcomes
Metabolic monitoring
Time frame: measured over a 7-8 hours period
physical monitoring
Time frame: two hours and four hours after concumption
mental monitoring
Time frame: 3.3 hours after intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Atkin, Prof. Dr. principal investigator
Hull University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cocoa-based food in people with Motor Activity, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose concentration (time frame: Baseline will be fasting, and monitoring measures up to 7 hours after consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.