Glycogen Metabolism in Children

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Breakfast 1; Other: Water; Other: Breakfast 2

• Registration Number: NCT04278209
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

Study Timeline

• Study Start: 2020-01-23
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

1. Girls having menstruations
2. Any type of self-reported food allergies
3. Lactose intolerance
4. Claustrophobic
5. Diagnosis of Diabetes Mellitus
6. Diagnosed acute or chronic medical conditions that could impact study outcomes (asthma)
7. Ongoing diseases or intake of any prescribed or over the counter drugs
8. 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)
9. Currently participating or having participated in another clinical trial within 12 weeks prior to trial start.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Breakfast 1 - water	Water	Participants will receive Breakfast 1, then water.
Water - Breakfast 2	Water	Participants will receive water, then Breakfast 2.
Breakfast 1 - Breakfast 2	Breakfast 2	Participants will receive Breakfast 1 then Breakfast 2.
Breakfast 2 - Breakfast 1	Breakfast 1	Participants will receive 2 servings, then 1 serving of the study product.
Water - Breakfast 1	Water	Participants will receive water, then Breakfast 1.
Breakfast 1 - Breakfast 2	Breakfast 1	Participants will receive Breakfast 1 then Breakfast 2.
Breakfast 1 - water	Breakfast 1	Participants will receive Breakfast 1, then water.
Water - Breakfast 1	Breakfast 1	Participants will receive water, then Breakfast 1.
Breakfast 2 - Breakfast 1	Breakfast 2	Participants will receive 2 servings, then 1 serving of the study product.
Water - Breakfast 2	Breakfast 2	Participants will receive water, then Breakfast 2.
Breakfast 2 - water	Breakfast 2	Participants will receive Breakfast 2, then water.
Breakfast 2 - water	Water	Participants will receive Breakfast 2, then water.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Nottingham Medical School; 🇬🇧 Nottingham, United Kingdom