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Horton & Maizy Pilot Study for Resistant to Starch

Pennington Biomedical Research Center logo

Pennington Biomedical Research Center

Status

Completed

Conditions

pH
Weight Gain

Study type

Observational

Funder types

Other

Identifiers

NCT01338571
PBRC 28012

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

5 to 15 years old

Volunteers

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.

Trial design

4 participants in 1 patient group

Healthly children
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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