Horton & Maizy Pilot Study for Resistant to Starch

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01338571

Enrollment

Registered

2011-04-19

Start date

2008-02-29

Completion date

2008-07-31

Last updated

2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pH, Weight Gain

Keywords

stool fatty acid

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results