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

NCT ID: NCT01094652

Last Updated: 2012-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-04-30

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.

Conditions

Healthy

Keywords

Adolescent; Whole grain; Digestive health; Dietary fiber; Grain; Microbiota; Inflammation; Mucosal Immunity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Whole grain diet

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Refined grain diet

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Mills

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bobbi Langkamp-Henken, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Westwood Middle School

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23014489 (View on PubMed)

Other Identifiers

480-2009

Identifier Type: -

Identifier Source: org_study_id