Carbohydrate MetabolismNCT03185884
Carbohydrates and Children
A study testing Experimental in people with Carbohydrate Metabolism, run by Abbott Nutrition at 1 site in United States.
Trial summary
This study will evaluate the impact of test carbohydrate blends on fat and carbohydrate oxidation, glucose, insulin and hunger scores in pre-adolescent boys and girls. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbohydrate Metabolism
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2017to 12 Aug 2017
- 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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male 9 -13 years of age, or female 9- 10 years of age
- Tanner stage 1
- Subject was born full term
- Subject was born normal weight
- Subject passes the Physical Activity Readiness Questionnaire
- Body mass index >5th percentile and <95th percentile for age and gender
- Subject has voluntarily signed and dated a youth assent document
Who cannot join
- History of metabolic. endocrine, or hyperactivity disorders
- Allergy or intolerance to any ingredient found in the study products
- Participation in a concomitant trial of a non-registered drug or that otherwise conflicts with this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska-Lincoln
Lincoln, Nebraska, 68583-0806
About this study
Official title: An Evaluation of Carbohydrates and Children
This study will evaluate the impact of test carbohydrate blends on fat and carbohydrate oxidation, glucose, insulin and hunger scores in pre-adolescent boys and girls.
- Conditions
- Carbohydrate Metabolism
- Being tested
- Control, Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
control carbohydrate blend
ExperimentalOther
experimental carbohydrate blend
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | - 237 ml beverage; consumed once per test visit Receives: Other: Control |
| Experimental | Experimental | - 237 ml beverage; consumed once per test visit Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Utilization
Calculated by Indirect Calorimetry using volume of oxygen consumed (liters/minute) and the volume of carbon dioxide expired (liters/minute).
Measured: Study Visits 1 to 2 (1- 14 days)
Secondary outcomes (3)
Hunger Assessment
Visual analog scale (units on a scale)
Measured: Study Visits 1 to 2 (1- 14 days)
Blood Measurements - Glucose
mg/dl
Measured: Study Visits 1 to 2 (1- 14 days)
Blood Measurements - Insulin
IU
Measured: Study Visits 1 to 2 (1- 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start3 Jul 2017
- Primary completion12 Aug 2017
- Study completion12 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carbohydrate MetabolismStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikkie Mustad, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185884
- Sponsor's protocol ID
- AL25
- Status last verified
- Aug 2017
- First submitted
- 22 May 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gillen ZM, Mustad VA, Shoemaker ME, Mckay BD, Leutzinger TJ, Lopez-Pedrosa JM, Rueda R, Cramer JT. Impact of slow versus rapid digesting carbohydrates on substrate oxidation in pre-pubertal children: A randomized crossover trial. Clin Nutr. 2021 Jun;40(6):3718-3728. doi: 10.1016/j.clnu.2021.05.004. Epub 2021 May 11.
PubMed 34130017Shoemaker ME, Gillen ZM, Mckay BD, Leutzinger TJ, Mustad VA, Cramer JT. Endogenous versus exogenous carbohydrate oxidation measured by stable isotopes in pre-pubescent children plus 13C abundances in foods consumed three days prior. Metabol Open. 2020 Jul 15;7:100041. doi: 10.1016/j.metop.2020.100041. eCollection 2020 Sep.
PubMed 32812942
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Carbohydrates and Children
- ClinicalTrials.gov ID
- NCT03185884
- Acronym / sponsor ID
- AL25
- Conditions
- Carbohydrate Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 12 Aug 2017 (actual)
- First posted
- 14 Jun 2017 (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.
This study will evaluate the impact of test carbohydrate blends on fat and carbohydrate oxidation, glucose, insulin and hunger scores in pre-adolescent boys and girls.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control- 237 ml beverage; consumed once per test visit |
| Experimental | Experimental | Other: Experimental- 237 ml beverage; consumed once per test visit |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male 9 -13 years of age, or female 9- 10 years of age
- Tanner stage 1
- Subject was born full term
- Subject was born normal weight
- Subject passes the Physical Activity Readiness Questionnaire
Key exclusion criteria (3 listed)
- History of metabolic. endocrine, or hyperactivity disorders
- Allergy or intolerance to any ingredient found in the study products
- Participation in a concomitant trial of a non-registered drug or that otherwise conflicts with this study
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 |
|---|---|---|
| Controlcontrol carbohydrate blend | Other | Control |
| Experimentalexperimental carbohydrate blend | Other | Experimental |
Primary outcome
Energy Utilization
Time frame: Study Visits 1 to 2 (1- 14 days)
Calculated by Indirect Calorimetry using volume of oxygen consumed (liters/minute) and the volume of carbon dioxide expired (liters/minute).
3 secondary outcomes
Hunger Assessment
Time frame: Study Visits 1 to 2 (1- 14 days)
Blood Measurements - Glucose
Time frame: Study Visits 1 to 2 (1- 14 days)
Blood Measurements - Insulin
Time frame: Study Visits 1 to 2 (1- 14 days)
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 1 Sep 2017.
- Derived from this study: PubMed 34130017Gillen ZM, Mustad VA, Shoemaker ME, Mckay BD, Leutzinger TJ, Lopez-Pedrosa JM, Rueda R, Cramer JT. Impact of slow versus rapid digesting carbohydrates on substrate oxidation in pre-pubertal children: A randomized crossover trial. Clin Nutr. 2021 Jun;40(6):3718-3728. doi: 10.1016/j.clnu.2021.05.004. Epub 2021 May 11.
- Derived from this study: PubMed 32812942Shoemaker ME, Gillen ZM, Mckay BD, Leutzinger TJ, Mustad VA, Cramer JT. Endogenous versus exogenous carbohydrate oxidation measured by stable isotopes in pre-pubescent children plus 13C abundances in foods consumed three days prior. Metabol Open. 2020 Jul 15;7:100041. doi: 10.1016/j.metop.2020.100041. eCollection 2020 Sep.
- Individual participant dataSharing planned: Undecided
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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.
Vikkie Mustad, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Carbohydrate Metabolism, run by Abbott Nutrition at 1 site in United States.
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 7 inclusion and 3 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 1 Sep 2017. 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 States. 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?
Energy Utilization (time frame: Study Visits 1 to 2 (1- 14 days)). 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 NCT03185884, which also lists 2 linked publications.
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 1 Sep 2017.