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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breakfast 1 - Breakfast 2 | Experimental | Participants will receive Breakfast 1 then Breakfast 2. |
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| Breakfast 1 - water | Experimental | Participants will receive Breakfast 1, then water. |
|
| Breakfast 2 - water | Experimental | Participants will receive Breakfast 2, then water. |
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| Breakfast 2 - Breakfast 1 | Experimental | Participants will receive 2 servings, then 1 serving of the study product. |
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| Water - Breakfast 1 | Experimental | Participants will receive water, then Breakfast 1. |
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| Water - Breakfast 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breakfast 1 | Other | Participant will receive Breakfast 1 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liz Simpson, PhD | University of Nottingham Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham Medical School | Nottingham | NG7 2RD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36797201 | Derived | Horstman AM, Bawden SJ, Spicer A, Darwish N, Goyer A, Egli L, Rupp N, Minehira K, Gowland P, Breuille D, Macdonald IA, Simpson EJ. Liver glycogen stores via 13C magnetic resonance spectroscopy in healthy children: randomized, controlled study. Am J Clin Nutr. 2023 Apr;117(4):709-716. doi: 10.1016/j.ajcnut.2023.01.014. Epub 2023 Jan 20. |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Randomized, controlled, balanced incomplete crossover design
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Open Label
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Participants will receive water, then Breakfast 2. |
|
| Breakfast 2 | Other | Participant will receive Breakfast 2 |
|
| Water | Other | Participant will receive water |
|
| 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 |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |