Glycogen Metabolism in Children

January 25, 2022 updated by: Nestlé

Measurement of Glycogen Replenishment in Children After an Overnight Fast

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2RD
        • University of Nottingham Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breakfast 1 - Breakfast 2
Participants will receive Breakfast 1 then Breakfast 2.
Other: Breakfast 1
Participant will receive Breakfast 1
Other: Breakfast 2
Participant will receive Breakfast 2
Experimental: Breakfast 1 - water
Participants will receive Breakfast 1, then water.
Other: Breakfast 1
Participant will receive Breakfast 1
Other: Water
Participant will receive water
Experimental: Breakfast 2 - water
Participants will receive Breakfast 2, then water.
Other: Breakfast 2
Participant will receive Breakfast 2
Other: Water
Participant will receive water
Experimental: Breakfast 2 - Breakfast 1
Participants will receive 2 servings, then 1 serving of the study product.
Other: Breakfast 1
Participant will receive Breakfast 1
Other: Breakfast 2
Participant will receive Breakfast 2
Experimental: Water - Breakfast 1
Participants will receive water, then Breakfast 1.
Other: Breakfast 1
Participant will receive Breakfast 1
Other: Water
Participant will receive water
Experimental: Water - Breakfast 2
Participants will receive water, then Breakfast 2.
Other: Breakfast 2
Participant will receive Breakfast 2
Other: Water
Participant will receive water

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Liz Simpson, PhD, University of Nottingham Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2020

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1906NRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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