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Clinical Trials/NCT03185884
NCT03185884
Completed
Not Applicable

An Evaluation of Carbohydrates and Children

Abbott Nutrition1 site in 1 country20 target enrollmentJuly 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carbohydrate Metabolism
Sponsor
Abbott Nutrition
Enrollment
20
Locations
1
Primary Endpoint
Energy Utilization
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 3, 2017
End Date
August 12, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Blood Measurements - Insulin(Study Visits 1 to 2 (1- 14 days))
  • Hunger Assessment(Study Visits 1 to 2 (1- 14 days))
  • Blood Measurements - Glucose(Study Visits 1 to 2 (1- 14 days))

Study Sites (1)

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