Weight Gain Clinical Trial
Official title:
The Effect of Resistant Starch on the Stool Microflora of Children: A Pilot Study
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | July 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years to 15 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Pennington Biomedical Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 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. | Four weeks | No |
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