Horton & Maizy Pilot Study for Resistant to Starch

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

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.

Study Overview

• Status: Completed
• Conditions: pH; Weight Gain

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 Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children between ages 5 and 15

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthly children; Children will be given yogurt twice a day for four weeks. The dose for an adult is 8 ounces of yogurt twice a day. The dose will be scaled to the children based upon surface area dosing charts, but will not exceed a resistant starch load of 1 gram per year of age plus 10 grams10.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: stool fatty acid
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: PBRC 28012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No