Glycogen Metabolism in Children

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Other: Breakfast 2; Other: Breakfast 1; Other: Water

Study type: Interventional

Funder types: Industry

Identifiers

NCT04278209

1906NRC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Breakfast 1 - Breakfast 2

Experimental group

Description:

Participants will receive Breakfast 1 then Breakfast 2.

Treatment:

Other: Breakfast 2

Other: Breakfast 1

Breakfast 1 - water

Experimental group

Description:

Participants will receive Breakfast 1, then water.

Treatment:

Other: Water

Other: Breakfast 1

Breakfast 2 - water

Experimental group

Description:

Participants will receive Breakfast 2, then water.

Treatment:

Other: Breakfast 2

Other: Water

Breakfast 2 - Breakfast 1

Experimental group

Description:

Participants will receive 2 servings, then 1 serving of the study product.

Treatment:

Other: Breakfast 2

Other: Breakfast 1

Water - Breakfast 1

Experimental group

Description:

Participants will receive water, then Breakfast 1.

Treatment:

Other: Water

Other: Breakfast 1

Water - Breakfast 2

Experimental group

Description:

Participants will receive water, then Breakfast 2.

Treatment:

Other: Breakfast 2

Other: Water