Clinical trial NCT01094652: The Addition of Whole Grains to the Diets of Middle-school Children
Official title: The Addition of Whole Grains to the Diets of Middle-school Children: A Study of Digestive Health and Immune Defenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Adolescent
Whole grain
Digestive health
Dietary fiber
Grain
Microbiota
Inflammation
Mucosal Immunity
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2010-03-29
Enrollment: 83
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Middle-school student at Westwood Middle School, Gainesville, FL
* Parental/guardian consent
* Willing to eat three different study foods each day for six weeks
* Willing to provide two blood samples and two saliva samples over the course of the study

Exclusion Criteria:

* Taking medications for constipation or diarrhea
* Antibiotic therapy within the past four weeks prior to randomization
* Takes probiotics or consumes greater than three servings of yogurt per week
* Has any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-modulating diseases (HIV, AIDS, autoimmune, hepatitis, cancer, etc.)
* Has any food allergies (wheat, soy, egg, milk, gluten, nuts, or any other food or food ingredient)

Primary outcomes:
measure: Stool frequency
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in overall microbiota diversity
timeFrame: 6 weeks
measure: Inflammatory markers
timeFrame: 6 weeks
measure: Secretory IgA
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Westwood Middle School
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langkamp-Henken B, Nieves C Jr, Culpepper T, Radford A, Girard SA, Hughes C, Christman MC, Mai V, Dahl WJ, Boileau T, Jonnalagadda SS, Thielecke F. Fecal lactic acid bacteria increased in adolescents randomized to whole-grain but not refined-grain foods, whereas inflammatory cytokine production decreased equally with both interventions. J Nutr. 2012 Nov;142(11):2025-32. doi: 10.3945/jn.112.164996. Epub 2012 Sep 26.