Horton & Maizy Pilot Study for Resistant to Starch

Weight Gain Clinical Trial

Official title:

The Effect of Resistant Starch on the Stool Microflora of Children: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338571
• Other study ID #: PBRC 28012
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: December 17, 2015
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• pH
• Weight Gain

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of resistant starch on weight gain in children	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.	Four weeks	No
Secondary	Effect of resistant starch on weight gain in children	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.	Four weeks	No