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Completed

NCT Number: NCT01094652

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

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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Key information

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westwood Middle School

Gainesville, Florida, 32605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Whole grain diet

Dietary Supplement

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.

Refined grain diet

Dietary Supplement

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.

Primary outcomes

  1. Stool frequency

    Time frame: 6 weeks

Secondary outcomes

  1. Changes in overall microbiota diversity

    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.

  2. Inflammatory markers

    Time frame: 6 weeks

    Serum CRP, fibrinogen, IL-1, IL-6, and antioxidant capacity; mitogen-induced cytokine production including Th1, Th2, and inflammatory cytokines

  3. Secretory IgA

    Time frame: 6 weeks

    Salivary and fecal sIgA

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • General Mills

Registry information

Official study title

The Addition of Whole Grains to the Diets of Middle-school Children: A Study of Digestive Health and Immune Defenses

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 29, 2010
Registry last updated
Aug 2, 2012

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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