Glycogen Metabolism in Children

  • STATUS
    Recruiting
  • participants needed
    16
  • sponsor
    Nestlé
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Updated on 16 February 2024
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health screening

Summary

It is not fully understood in children how much of hepatic and muscle glycogen is used during a night and how they are replenished after a breakfast. This study aims to analyze the glycogen metabolism before and after an overnight sleep as well as after a breakfast in children between 8 and 12 years old.

Description

The aim of the study is to investigate if liver and muscle glycogen stores are depleted in children after overnight fasting and to what extend the stores are replenished with the intake of small breakfast.

The study is a balanced incomplete crossover design. Participants (children between 8 and 12 years old) have to be two periods of two days in the study. They will be randomized in 6 arms, receiving either water, 1 serving of a small breakfast (Breakfast 1) or 2 servings of the small breakfast (Breakfast 2).

Details
Condition Healthy
Age 8years - 12years
Treatment Water, Breakfast 1, Breakfast 2
Clinical Study IdentifierNCT04278209
SponsorNestlé
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Healthy girls and boys between 8 and 12 years of age
Clinically healthy body weight (5 to 85th rounded percentile from UK)
In good health as determined by health screening questionnaires
English proficiency as per investigator judgment
Informed consent signed by parent(s), or legal representative if applicable and signed child assent according to local legislation

Exclusion Criteria

Girls having menstruations
Any type of self-reported food allergies
Lactose intolerance
Claustrophobic
Diagnosis of Diabetes Mellitus
Diagnosed acute or chronic medical conditions that could impact study outcomes (asthma)
Ongoing diseases or intake of any prescribed or over the counter drugs
Participants or participants' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol (including a consumption of 200 ml study drink)
Currently participating or having participated in another clinical trial within 12 weeks prior to trial start
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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