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

This study has been completed.
Sponsor:
Collaborator:
General Mills Inc.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01094652
First received: March 23, 2010
Last updated: August 1, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: Whole grain diet
Dietary Supplement: Refined grain diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Addition of Whole Grains to the Diets of Middle-school Children: A Study of Digestive Health and Immune Defenses

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Stool frequency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in overall microbiota diversity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Inflammatory markers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Serum CRP, fibrinogen, IL-1, IL-6, and antioxidant capacity; mitogen-induced cytokine production including Th1, Th2, and inflammatory cytokines

  • Secretory IgA [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Salivary and fecal sIgA


Enrollment: 83
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole grain diet
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.
Dietary Supplement: Whole grain diet
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.
Active Comparator: Refined grain diet
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.
Dietary Supplement: Refined grain diet
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.

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

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094652

Locations
United States, Florida
Westwood Middle School
Gainesville, Florida, United States, 32605
Sponsors and Collaborators
University of Florida
General Mills Inc.
Investigators
Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida
  More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01094652     History of Changes
Other Study ID Numbers: 480-2009
Study First Received: March 23, 2010
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Adolescent
Whole grain
Digestive health
Dietary fiber
Grain
Microbiota
Inflammation
Mucosal Immunity

ClinicalTrials.gov processed this record on October 01, 2014