Carbohydrates and Children
An Evaluation of Carbohydrates and Children
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
July 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2017
CompletedSeptember 1, 2017
August 1, 2017
1 month
May 22, 2017
August 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Energy Utilization
Calculated by Indirect Calorimetry using volume of oxygen consumed (liters/minute) and the volume of carbon dioxide expired (liters/minute).
Study Visits 1 to 2 (1- 14 days)
Secondary Outcomes (3)
Hunger Assessment
Study Visits 1 to 2 (1- 14 days)
Blood Measurements - Glucose
Study Visits 1 to 2 (1- 14 days)
Blood Measurements - Insulin
Study Visits 1 to 2 (1- 14 days)
Study Arms (2)
Control
ACTIVE COMPARATOR\- 237 ml beverage; consumed once per test visit
Experimental
EXPERIMENTAL\- 237 ml beverage; consumed once per test visit
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
University of Nebraska-Lincoln
Lincoln, Nebraska, 68583-0806, United States
Related Publications (2)
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.
PMID: 34130017DERIVEDShoemaker 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.
PMID: 32812942DERIVED
Study Officials
- STUDY CHAIR
Vikkie Mustad, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2017
First Posted
June 14, 2017
Study Start
July 3, 2017
Primary Completion
August 12, 2017
Study Completion
August 12, 2017
Last Updated
September 1, 2017
Record last verified: 2017-08