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OpenTrials
Completed

NCT Number: NCT03185884

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.

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Key information

Conditions

Carbohydrate Metabolism

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska-Lincoln

Lincoln, Nebraska, 68583-0806, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

control carbohydrate blend

Experimental

Other

experimental carbohydrate blend

Primary outcomes

  1. 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

  1. Hunger Assessment

    Time frame: Study Visits 1 to 2 (1- 14 days)

    Visual analog scale (units on a scale)

  2. Blood Measurements - Glucose

    Time frame: Study Visits 1 to 2 (1- 14 days)

    mg/dl

  3. Blood Measurements - Insulin

    Time frame: Study Visits 1 to 2 (1- 14 days)

    IU

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

An Evaluation of Carbohydrates and Children

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2017
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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