Horton & Maizy Pilot Study for Resistant to Starch

NCT01338571 — Completed, 4 participants, Pennington Biomedical Research Center

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

Registry	NCT01338571
Status	Completed
Study type	Observational
Enrollment	4 (Actual)
Sponsor	Pennington Biomedical Research Center (Other)
Conditions	pH, Weight Gain
Dates	start 2008-02-01, primary completion 2008-05-01, completion 2008-07-01, first posted 2011-04-19, last updated 2015-12-18
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 5 Years to 15 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Pennington Biomedical Research Center	Baton Rouge, Louisiana	United States