NCT01403857

Brief Summary

The specific aims of the Grain Study are to determine if exposure to different types of grain products, over a period of 6 weeks, changes liking and acceptability and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal function changes with consumption of whole grains or refined grains.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

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

April 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

July 5, 2011

Last Update Submit

March 8, 2024

Conditions

Food Preferences

Keywords

Acceptabilityliking

Outcome Measures

Primary Outcomes (2)

  • Change in the acceptability and liking of grain products

    Sensory evaluation of grain products

    0, 6 weeks

  • Change in the gut microbiota and their fermentation products

    To determine if gut microbiota change over the intervention and if those changes persist over the long term. Gut microbiota assessed using 16S methodology.

    0, 6 weeks

Secondary Outcomes (2)

  • Change in gastrointestinal function

    0, 6 weeks

  • Liking the taste of grain products

    0, 6 weeks

Study Arms (2)

Whole Grain

EXPERIMENTAL

Whole grain products as defined by the American Association of Cereal Chemists (AACC) given in a market basket that contains eight commonly used grain products over six weeks.

Other: Whole grain foods

Refined Grains

PLACEBO COMPARATOR

Time control compared to experimental intervention.

Other: Refined grains

Interventions

Whole grain foodsOTHER

Eight commonly consumed whole grain products that meet the consumers Dietary Guidelines recommendations for a period of six weeks.

Whole Grain
Refined grainsOTHER

Eight commonly consumed refined grain products given in amounts that fulfill the consumer's Dietary Guidelines for Americans recommendation over the course of six weeks.

Refined Grains

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • male or female
  • consumers of 1 or fewer whole grain products per day

You may not qualify if:

  • Type I or II Diabetes or glucose intolerance
  • Preference for whole grains
  • Do not cook at home
  • Pregnant or planning to be pregnant
  • Smoking
  • Chronic inflammatory bowel disease
  • colorectal cancer
  • Celiac disease or gluten sensitivity
  • Crohn's disease
  • Regular use of colonics and/or laxatives
  • body weight change of \>3% in last 6 months
  • use of antibiotics, appetite suppressants, mood altering medications, and regular tobacco use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (5)

  • Greenwald AG, Nosek BA, Banaji MR. Understanding and using the implicit association test: I. An improved scoring algorithm. J Pers Soc Psychol. 2003 Aug;85(2):197-216. doi: 10.1037/0022-3514.85.2.197.

    PMID: 12916565BACKGROUND

  • Cooper DN, Kable ME, Marco ML, De Leon A, Rust B, Baker JE, Horn W, Burnett D, Keim NL. The Effects of Moderate Whole Grain Consumption on Fasting Glucose and Lipids, Gastrointestinal Symptoms, and Microbiota. Nutrients. 2017 Feb 21;9(2):173. doi: 10.3390/nu9020173.

    PMID: 28230784RESULT

  • Cooper DN, Martin RJ, Keim NL. Does Whole Grain Consumption Alter Gut Microbiota and Satiety? Healthcare (Basel). 2015 May 29;3(2):364-92. doi: 10.3390/healthcare3020364.

    PMID: 27417768RESULT

  • De Leon A, Burnett DJ, Rust BM, Casperson SL, Horn WF, Keim NL. Liking and Acceptability of Whole Grains Increases with a 6-Week Exposure but Preferences for Foods Varying in Taste and Fat Content Are Not Altered: A Randomized Controlled Trial. Curr Dev Nutr. 2020 Mar 9;4(3):nzaa023. doi: 10.1093/cdn/nzaa023. eCollection 2020 Mar.

    PMID: 32190809RESULT

  • De Leon A, Burnett DJ, Rust B, Lyly M, Keim NL. Initial implicit association between whole grains and taste does not predict consumption of whole grains in low-whole grain consumers: a pilot randomized controlled trial. Front Nutr. 2024 Sep 30;11:1408256. doi: 10.3389/fnut.2024.1408256. eCollection 2024.

    PMID: 39403397DERIVED

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Nancy Keim, PhD

    USDA, Western Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

  • William Horn, MS

    USDA, Western Human Nutrition Research Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 27, 2011

Study Start

April 1, 2010

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

US(1)