Carbohydrates and Children

Carbohydrate Metabolism Clinical Trial

Official title:

An Evaluation of Carbohydrates and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185884
• Other study ID #: AL25
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: August 31, 2017
• Start date: July 3, 2017
• Est. completion date: August 12, 2017

Study information

• Verified date: August 2017
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 12, 2017
• Est. primary completion date: August 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Carbohydrate Metabolism

Intervention

Other:
• Control
control carbohydrate blend
• Experimental
experimental carbohydrate blend

Locations

Country	Name	City	State
United States	University of Nebraska-Lincoln	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hunger Assessment	Visual analog scale (units on a scale)	Study Visits 1 to 2 (1- 14 days)
Secondary	Blood Measurements - Glucose	mg/dl	Study Visits 1 to 2 (1- 14 days)
Secondary	Blood Measurements - Insulin	IU	Study Visits 1 to 2 (1- 14 days)