NCT04278209

Glycogen Metabolism in Children

Measurement of Glycogen Replenishment in Children After an Overnight Fast

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed 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). 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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Breakfast 1	Participant will receive Breakfast 1
OTHER	Breakfast 2	Participant will receive Breakfast 2
OTHER	Water	Participant will receive water

Timeline

• Start date: 2020-01-23
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2020-02-20
• Last updated: 2022-01-26

Locations

1 site across 1 country: United Kingdom