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Completed

NCT Number: NCT01338571

Horton & Maizy Pilot Study for Resistant to Starch

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.

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Key information

Conditions

pH Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Effect of resistant starch on weight gain in children

    Time frame: 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 outcomes

  1. Effect of resistant starch on weight gain in children

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 19, 2011
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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