HealthyNCT04278209
Glycogen Metabolism in Children
A study testing Breakfast 1, Breakfast 2 and Water in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Breakfast 1, Breakfast 2 and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jan 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham Medical School
Nottingham, NG7 2RD
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast 1Other
Participant will receive Breakfast 1
Breakfast 2Other
Participant will receive Breakfast 2
WaterOther
Participant will receive water
| Study group | Role | What they receive |
|---|---|---|
| Breakfast 1 - Breakfast 2 | Experimental | Participants will receive Breakfast 1 then Breakfast 2. Receives: Other: Breakfast 1; Other: Breakfast 2 |
| Breakfast 1 - water | Experimental | Participants will receive Breakfast 1, then water. Receives: Other: Breakfast 1; Other: Water |
| Breakfast 2 - water | Experimental | Participants will receive Breakfast 2, then water. Receives: Other: Breakfast 2; Other: Water |
| Breakfast 2 - Breakfast 1 | Experimental | Participants will receive 2 servings, then 1 serving of the study product. Receives: Other: Breakfast 1; Other: Breakfast 2 |
| Water - Breakfast 1 | Experimental | Participants will receive water, then Breakfast 1. Receives: Other: Breakfast 1; Other: Water |
| Water - Breakfast 2 | Experimental | Participants will receive water, then Breakfast 2. Receives: Other: Breakfast 2; Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours
Secondary outcomes (3)
Change of hepatic glycogen content over an overnight fast
Change of hepatic glycogen content over an overnight fast
Measured: 12 hours
Change of muscle glycogen content over an overnight fast
Change of muscle glycogen content over an overnight fast
Measured: 12 hours
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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start23 Jan 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled, balanced incomplete crossover design
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liz Simpson, PhD, Principal investigator, University of Nottingham Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278209
- Sponsor's protocol ID
- 1906NRC
- Status last verified
- Jan 2022
- First submitted
- 18 Feb 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36797201
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Glycogen Replenishment in Children After an Overnight Fast
- ClinicalTrials.gov ID
- NCT04278209
- Acronym / sponsor ID
- 1906NRC
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Randomized, controlled, balanced incomplete crossover design
| Arm | Type | Receives |
|---|---|---|
| Breakfast 1 - Breakfast 2 | Experimental | Other: Breakfast 1, Other: Breakfast 2Participants will receive Breakfast 1 then Breakfast 2. |
| Breakfast 1 - water | Experimental | Other: Breakfast 1, Other: WaterParticipants will receive Breakfast 1, then water. |
| Breakfast 2 - water | Experimental | Other: Breakfast 2, Other: WaterParticipants will receive Breakfast 2, then water. |
| Breakfast 2 - Breakfast 1 | Experimental | Other: Breakfast 1, Other: Breakfast 2Participants will receive 2 servings, then 1 serving of the study product. |
| Water - Breakfast 1 | Experimental | Other: Breakfast 1, Other: WaterParticipants will receive water, then Breakfast 1. |
| Water - Breakfast 2 | Experimental | Other: Breakfast 2, Other: WaterParticipants will receive water, then Breakfast 2. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Girls having menstruations
- Any type of self-reported food allergies
- Lactose intolerance
- Claustrophobic
- Diagnosis of Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast 1Participant will receive Breakfast 1 | Other | Breakfast 1 - Breakfast 2, Breakfast 1 - water, Breakfast 2 - Breakfast 1, Water - Breakfast 1 |
| Breakfast 2Participant will receive Breakfast 2 | Other | Breakfast 1 - Breakfast 2, Breakfast 2 - Breakfast 1, Breakfast 2 - water, Water - Breakfast 2 |
| WaterParticipant will receive water | Other | Breakfast 1 - water, Breakfast 2 - water, Water - Breakfast 1, Water - Breakfast 2 |
Primary outcome
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
3 secondary outcomes
Change of hepatic glycogen content over an overnight fast
Time frame: 12 hours
Change of muscle glycogen content over an overnight fast
Time frame: 12 hours
Incremental/decremental AUC0-240 of the concentration/time curve of muscle glycogen
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Derived from this study: PubMed 36797201Horstman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liz Simpson, PhD principal investigator
University of Nottingham Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast 1, Breakfast 2 and Water in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental/decremental AUC0-240 of the concentration/time curve of hepatic glycogen (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.