Bioavailability and Dosing of a Monosaccharide Supplement in Adults

This study has been completed.
Sponsor:
Collaborators:
University of Arkansas
USDA Beltsville Human Nutrition Research Center
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00782392
First received: October 29, 2008
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

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.


Condition
Healthy Males

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Bioavailability and Dosing of an Oral Monosaccharide Supplement in Adults and Effects on Resting Brain Activity

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 15
Study Start Date: January 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 28 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Caucasian Males

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782392

Locations
United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas
USDA Beltsville Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: Joanne S. Szabo, M.D., University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00782392     History of Changes
Other Study ID Numbers: 45092
Study First Received: October 29, 2008
Last Updated: May 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Nutrition
Infant Formula

ClinicalTrials.gov processed this record on September 22, 2014