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Horton & Maizy Pilot Study for Resistant to Starch

NCT ID: NCT01338571

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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pH Weight Gain

Keywords

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stool fatty acid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 28012

Identifier Type: -

Identifier Source: org_study_id