NCT00782392

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
Last Updated

May 18, 2011

Status Verified

May 1, 2011

Enrollment Period

5 months

First QC Date

October 29, 2008

Last Update Submit

May 16, 2011

Conditions

Keywords

NutritionInfant Formula

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Caucasian Males

You may qualify if:

  • Caucasian (non-hispanic)
  • Male
  • Age 18-28
  • Regularly eat breakfast
  • Healthy
  • BMI within normal limits (18.5 - 24.9)
  • English speaking

You may not qualify if:

  • History of smoking, more than occasional alcohol use, or drug use.
  • Chronic medical diagnosis
  • Medications that may interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2008

First Posted

October 31, 2008

Study Start

January 1, 2007

Primary Completion

June 1, 2007

Last Updated

May 18, 2011

Record last verified: 2011-05

Locations