Westwood Middle School
Gainesville, Florida, 32605, United States
NCT Number: NCT01094652
The Dietary Guidelines for Americans recommend that children and adolescents "consume whole-grain products often; at least half the grains should be whole grains." Few, if any studies, examine the benefit of whole grains on the health of adolescents. The purpose of this study is to determine if adolescents eating diets rich in whole grains vs. diets rich in refined grains (i.e., a typical diet) have improved markers of digestive and immune health.
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Notify Me11 year–15 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32605, United States
Middle-school students will be recruited and randomized to receive >/=80 g of whole grains (>/=5 servings) or similar foods made with refined grains each day for six weeks. Based on treatment group, subjects will be provided either whole grain or refined grain foods and snacks. They will be instructed on how to use these foods to replace other foods already contained in the diet. Stool, blood, and saliva samples will be obtained at baseline and at study end to examine the microbiota and markers of digestive and immune health. Daily records will be maintained by the students to assess bowel habits and compliance. It is anticipated that whole grains will increase stool bulk resulting in increased stool frequency and softer stools. Additionally, fermentation of the fiber within the colon will alter the microbiota profile. Because the majority of the immune system resides within the gastrointestinal tract, improved balance of the intestinal microbiota may prime the immune system thus contributing to improved immune defense.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects were told to consume three different kinds of study food each day. The goal was an intake of greater than or equal to 80 g of whole grains per day.
The refined grain food products were matched as closely as possible to the foods contained in the whole grain diet. Subjects were told to consume three different kinds of study food each day.
Time frame: 6 weeks
Time frame: 6 weeks
Microbial diversity will be measured by DGGE profiling to detect large distortions. Quantitative changes in the proportions of select bacteria will be measured using qPCR.
Time frame: 6 weeks
Serum CRP, fibrinogen, IL-1, IL-6, and antioxidant capacity; mitogen-induced cytokine production including Th1, Th2, and inflammatory cytokines
Time frame: 6 weeks
Salivary and fecal sIgA
University of Florida
Other
The Addition of Whole Grains to the Diets of Middle-school Children: A Study of Digestive Health and Immune Defenses
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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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