Horton & Maizy Pilot Study for Resistant to Starch

Completed

• Conditions: pH; Weight Gain

• Registration Number: NCT01338571
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

This is a pilot study and will be used to power an NIH grant application on the effect of resistant starch on weight gain in children.

Detailed Description

Stool fatty acids and stool pH from the baseline and week 4 stool samples will be compared by paired-t test. The stool microflora changes will be reported using descriptive statistics for the percent changes in the different bacterial phyla.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Healthy male or female between the ages of 5 and 15 years

Exclusion Criteria

• Gastrointestinal disease
• Medication such as antibiotics that have the potential for altering the gut bacterial flora.
• Allergic to milk or corn products.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of resistant starch on weight gain in children	Four weeks	During the 4 weeks while still consuming the yogurt supplements, 3 daily stool samples will be collected in the same manner as the baseline stool collections. Stool fatty acids from the baseline and week 4 stool samples will be compared by paired-t test. The stool microflora changes will be reported using descriptive statistics for the percent changes in the different bacterial phyla.

Secondary Outcome Measures

Name	Time	Method
Effect of resistant starch on weight gain in children	Four weeks	During the 4 weeks while still consuming the yogurt supplements, 3 daily stool samples will be collected in the same manner as the baseline stool collections. Stool pH from the baseline and week 4 stool samples will be compared by paired-t test. The stool microflora changes will be reported using descriptive statistics for the percent changes in the different bacterial phyla.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States