NCT04278209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

February 18, 2020

Last Update Submit

January 25, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change of hepatic glycogen content over an overnight fast

    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

    4 hours

Study Arms (6)

Breakfast 1 - Breakfast 2

EXPERIMENTAL

Participants will receive Breakfast 1 then Breakfast 2.

Other: Breakfast 1Other: Breakfast 2

Breakfast 1 - water

EXPERIMENTAL

Participants will receive Breakfast 1, then water.

Other: Breakfast 1Other: Water

Breakfast 2 - water

EXPERIMENTAL

Participants will receive Breakfast 2, then water.

Other: Breakfast 2Other: Water

Breakfast 2 - Breakfast 1

EXPERIMENTAL

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

Other: Breakfast 1Other: Breakfast 2

Water - Breakfast 1

EXPERIMENTAL

Participants will receive water, then Breakfast 1.

Other: Breakfast 1Other: Water

Water - Breakfast 2

EXPERIMENTAL

Participants will receive water, then Breakfast 2.

Other: Breakfast 2Other: Water

Interventions

Breakfast 1OTHER

Participant will receive Breakfast 1

Breakfast 1 - Breakfast 2Breakfast 1 - waterBreakfast 2 - Breakfast 1Water - Breakfast 1
Breakfast 2OTHER

Participant will receive Breakfast 2

Breakfast 1 - Breakfast 2Breakfast 2 - Breakfast 1Breakfast 2 - waterWater - Breakfast 2
WaterOTHER

Participant will receive water

Breakfast 1 - waterBreakfast 2 - waterWater - Breakfast 1Water - Breakfast 2

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham Medical School

Nottingham, NG7 2RD, United Kingdom

Location

Related Publications (1)

  • Horstman AM, Bawden SJ, Spicer A, Darwish N, Goyer A, Egli L, Rupp N, Minehira K, Gowland P, Breuille D, Macdonald IA, Simpson EJ. Liver glycogen stores via 13C magnetic resonance spectroscopy in healthy children: randomized, controlled study. Am J Clin Nutr. 2023 Apr;117(4):709-716. doi: 10.1016/j.ajcnut.2023.01.014. Epub 2023 Jan 20.

    PMID: 36797201DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Liz Simpson, PhD

    University of Nottingham Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, controlled, balanced incomplete crossover design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

January 23, 2020

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

GB(1)