Glycogen Metabolism in Children

Healthy Clinical Trial

Official title:

Measurement of Glycogen Replenishment in Children After an Overnight Fast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278209
• Other study ID #: 1906NRC
• Status: Completed
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Breakfast 1
Participant will receive Breakfast 1
• Breakfast 2
Participant will receive Breakfast 2
• Water
Participant will receive water

Locations

Country	Name	City	State
United Kingdom	University of Nottingham Medical School	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change of hepatic glycogen content over an overnight fast	Change of hepatic glycogen content over an overnight fast	12 hours
Secondary	Change of muscle glycogen content over an overnight fast	Change of muscle glycogen content over an overnight fast	12 hours
Secondary	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