The Addition of Whole Grains to the Diets of Middle-school Children

University of Florida

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Refined grain diet; Dietary Supplement: Whole grain diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01094652

480-2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

83 participants in 2 patient groups

Whole grain diet

Experimental group

Description:

Participants in this group will be given whole grain snacks on school days and food packages consisting of whole grain breads, breakfast cereals, rice, snack foods, and pasta to replace their typical grains consumed at home.

Treatment:

Dietary Supplement: Whole grain diet

Refined grain diet

Active Comparator group

Description:

Participants in this group will be given refined grain snacks on school days and food packages consisting of refined grain breads, breakfast cereals, rice, snack foods, and pasta to replace their typical grains consumed at home.

Treatment:

Dietary Supplement: Refined grain diet