Horton & Maizy Pilot Study for Resistant to Starch

NCT01338571 | Completed

• 1 other identifier: PBRC 28012
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

pH; Weight Gain

Keywords

stool fatty acid

Outcome Measures

Primary Outcomes (1)

• Effect of resistant starch on weight gain in children

  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.

  Four weeks

Secondary Outcomes (1)

• Effect of resistant starch on weight gain in children

  Four weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children between ages 5 and 15

You may qualify if:

• Healthy male or female between the ages of 5 and 15 years

You may not qualify if:

• Gastrointestinal disease
• Medication such as antibiotics that have the potential for altering the gut bacterial flora.
• Allergic to milk or corn products.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Biospecimen

Retention: NONE RETAINED

collect 3 daily stool samples are retained at baseline and after 4 weeks

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: February 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

US (1)