NCT01094652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

2 months

First QC Date

March 23, 2010

Last Update Submit

August 1, 2012

Conditions

Healthy

Keywords

AdolescentWhole grainDigestive healthDietary fiberGrainMicrobiotaInflammationMucosal Immunity

Outcome Measures

Primary Outcomes (1)

  • Stool frequency

    6 weeks

Secondary Outcomes (3)

  • Changes in overall microbiota diversity

    6 weeks

  • Inflammatory markers

    6 weeks

  • Secretory IgA

    6 weeks

Study Arms (2)

Whole grain diet

EXPERIMENTAL

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

Refined grain diet

ACTIVE COMPARATOR

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

Interventions

Whole grain dietDIETARY_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.

Whole grain diet
Refined grain dietDIETARY_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.

Refined grain diet

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westwood Middle School

Gainesville, Florida, 32605, United States

Location

Related Publications (1)

  • 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.

    PMID: 23014489DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bobbi Langkamp-Henken, PhD, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 29, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

US(1)