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Horton & Maizy Pilot Study for Resistant to Starch

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT01338571
Collaborator
(none)
4
Enrollment
1
Location
5
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    4 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Resistant Starch on the Stool Microflora of Children: A Pilot Study
    Study Start Date :
    Feb 1, 2008
    Actual Primary Completion Date :
    May 1, 2008
    Actual Study Completion Date :
    Jul 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    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 Outcome Measures

    1. 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 Outcome Measures

    1. 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 Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT01338571
    Other Study ID Numbers:
    • PBRC 28012
    First Posted:
    Apr 19, 2011
    Last Update Posted:
    Dec 18, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
    stool fatty acid
    Additional relevant MeSH terms:
    Weight Gain

    Study Results

    No Results Posted as of Dec 18, 2015