Carbohydrates and Children

NCT ID: NCT03185884

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-03

Study Completion Date

2017-08-12

Brief Summary

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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.

Detailed Description

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Conditions

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Carbohydrate Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

\- 237 ml beverage; consumed once per test visit

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

control carbohydrate blend

Experimental

\- 237 ml beverage; consumed once per test visit

Group Type EXPERIMENTAL

Experimental

Intervention Type OTHER

experimental carbohydrate blend

Interventions

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Control

control carbohydrate blend

Intervention Type OTHER

Experimental

experimental carbohydrate blend

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikkie Mustad, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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University of Nebraska-Lincoln

Lincoln, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34130017 (View on PubMed)

Shoemaker 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.

Reference Type DERIVED
PMID: 32812942 (View on PubMed)

Other Identifiers

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AL25

Identifier Type: -

Identifier Source: org_study_id

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