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Carbohydrates and Children

An Evaluation of Carbohydrates and Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03185884
Enrollment
20
Registered
2017-06-14
Start date
2017-07-03
Completion date
2017-08-12
Last updated
2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbohydrate Metabolism

Brief 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.

Interventions

OTHERControl

control carbohydrate blend

OTHERExperimental

experimental carbohydrate blend

Sponsors

Abbott Nutrition
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Energy UtilizationStudy 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).

Secondary

MeasureTime frameDescription
Hunger AssessmentStudy Visits 1 to 2 (1- 14 days)Visual analog scale (units on a scale)
Blood Measurements - GlucoseStudy Visits 1 to 2 (1- 14 days)mg/dl
Blood Measurements - InsulinStudy Visits 1 to 2 (1- 14 days)IU

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026