Bioavailability and Dosing of a Monosaccharide Supplement in Adults

Healthy Males Clinical Trial

Official title:

Bioavailability and Dosing of an Oral Monosaccharide Supplement in Adults and Effects on Resting Brain Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782392
• Other study ID #: 45092
• Status: Completed
• Phase: N/A
• First received: October 29, 2008
• Last updated: May 16, 2011
• Start date: January 2007

Study information

• Verified date: May 2011
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We are developing an oral supplement of carbohydrates to be added to infant formulas in order to improve brain development, immune function, and overall health of infants and children. After a careful review of what is known about these sugars, there is very little information regarding their use in infants and children, although there is some information in adults and animals.

Many of these sugars have been used in a glyco-nutritional supplement in adults and children, with minimal or no reported side effects.

We are developing a custom blend of important individual sugars, and need information regarding their dosing and blood concentrations following oral intake of the carbohydrate supplement. Timed blood samples following the carbohydrate supplement will provide us with a better understanding of the most effective dose and the metabolism of these sugars in adults. This will give us the preliminary information we need for developing an oral supplement of special sugars that can be added to infant formulas to help improve brain development and immune function in infants and children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 28 Years

Eligibility

Inclusion Criteria:

• Caucasian (non-hispanic)

• Male

• Age 18-28

• Regularly eat breakfast

• Healthy

• BMI within normal limits (18.5 - 24.9)

• English speaking

Exclusion Criteria:

• History of smoking, more than occasional alcohol use, or drug use.

• Chronic medical diagnosis

• Medications that may interfere with the study

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy Males

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	United States Department of Agriculture (USDA), University of Arkansas

Country where clinical trial is conducted

United States,