Clinical trial NCT04278209: Glycogen Metabolism in Children
Official title: Measurement of Glycogen Replenishment in Children After an Overnight Fast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled, balanced incomplete crossover design
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incremental/decremental AUC0-240 of the concentration/time curve of hepatic glycogen
timeFrame: 4 hours
Secondary outcomes:
measure: Change of hepatic glycogen content over an overnight fast
timeFrame: 12 hours
measure: Change of muscle glycogen content over an overnight fast
timeFrame: 12 hours
measure: Incremental/decremental AUC0-240 of the concentration/time curve of muscle glycogen
timeFrame: 4 hours
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham Medical School
Study officials:
affiliation: University of Nottingham Medical School
name: Liz Simpson, PhD
role: PRINCIPAL_INVESTIGATOR
References: