Glycogen Metabolism in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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). An Interim Analysis after 9 completed subjects will be performed in order to calculate the total number of subjects needed to adequately power the Primary Endpoint.

Official Title
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Measurement of Glycogen Replenishment in Children After an Overnight Fast

Conditions
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Healthy

Intervention / Treatment
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* Other: Breakfast 1
* Other: Breakfast 2
* Other: Water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, controlled, balanced incomplete crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breakfast 1 - Breakfast 2<br>Participants will receive Breakfast 1 then Breakfast 2. | Other: Breakfast 1<br>* Participant will receive Breakfast 1<br>Other: Breakfast 2<br>* Participant will receive Breakfast 2<br>|
| Experimental: Breakfast 1 - water<br>Participants will receive Breakfast 1, then water. | Other: Breakfast 1<br>* Participant will receive Breakfast 1<br>Other: Water<br>* Participant will receive water<br>|
| Experimental: Breakfast 2 - water<br>Participants will receive Breakfast 2, then water. | Other: Breakfast 2<br>* Participant will receive Breakfast 2<br>Other: Water<br>* Participant will receive water<br>|
| Experimental: Breakfast 2 - Breakfast 1<br>Participants will receive 2 servings, then 1 serving of the study product. | Other: Breakfast 1<br>* Participant will receive Breakfast 1<br>Other: Breakfast 2<br>* Participant will receive Breakfast 2<br>|
| Experimental: Water - Breakfast 1<br>Participants will receive water, then Breakfast 1. | Other: Breakfast 1<br>* Participant will receive Breakfast 1<br>Other: Water<br>* Participant will receive water<br>|
| Experimental: Water - Breakfast 2<br>Participants will receive water, then Breakfast 2. | Other: Breakfast 2<br>* Participant will receive Breakfast 2<br>Other: Water<br>* Participant will receive water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental/decremental AUC0-240 of the concentration/time curve of hepatic glycogen | To determine the effects of 1 and 2 servings of a small breakfast on hepatic glycogen stores; measured by NMR | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of hepatic glycogen content over an overnight fast | Change of hepatic glycogen content over an overnight fast | 12 hours | 
| Change of muscle glycogen content over an overnight fast | Change of muscle glycogen content over an overnight fast | 12 hours | 
| Incremental/decremental AUC0-240 of the concentration/time curve of muscle glycogen | To determine the effects of 1 and 2 servings of a small breakfast on muscle glycogen stores; measured by NMR | 4 hours |