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Completed

NCT Number: NCT01403857

Evaluating Liking, Acceptability and Health Benefits of Grain Products

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

Subjects will be recruited in accordance with inclusion and exclusion criteria listed below. Subjects will be assigned to one of two different grain product 'exposure' groups - Group 1 will receive predominantly Whole Grain (WG) products and Group 2 will receive predominantly Refined Grain (RG) products (ratio of WG to RG assignment will be 2:1). For a 6-week exposure period, subjects will receive weekly market baskets of grain products consisting of breakfast cereals, breads, snack items, and side dishes with the target of providing whole grains at a level of 85% of grain intake for the WG group (this exceeds the current Dietary Guideline recommendation of 50%) and 15% for the RG group (this is the current estimated intake for U.S. adults). Before and after grain exposure, subjects will rate the acceptability and liking of numerous grain products. To accomplish this, subjects will participate in sensory evaluation tests using these products, and they will provide information using validated questionnaires and take implicit association tests. During the 6-week study period, subjects will record use of the market basket grain products, and provide subjective scores for taste, convenience, nutrition, and general liking. The quality of the total dietary intake will be assessed using unannounced 24-h recalls. Biological samples will also be collected from subjects. Blood and urine samples will be collected to evaluate risk factors of chronic disease, and biomarkers of whole grain intake, fruits and vegetables. Saliva and fecal samples will be collected to measure changes in gut microbiota and to measure metabolites of bacterial fermentation. Breath hydrogen tests will be conducted to measure bacterial fermentation. Two weeks after the end of the intervention period, subjects will participate in a nominal group session to identify significant barriers and facilitators to inclusion of grain products into their diets.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 20-45 years of age
  • male or female
  • consumers of 1 or fewer whole grain products per day

Exclusion criteria

  • 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.

Treatment and study plan

Whole grain foods

Other

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

Refined grains

Other

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.

Primary outcomes

  1. Change in the acceptability and liking of grain products

    Time frame: 0, 6 weeks

    Sensory evaluation of grain products

  2. Change in the gut microbiota and their fermentation products

    Time frame: 0, 6 weeks

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

Secondary outcomes

  1. Change in gastrointestinal function

    Time frame: 0, 6 weeks

    Change in gastrointestinal function assessed using a questionnaire and exhaled breath hydrogen (ppm).

  2. Liking the taste of grain products

    Time frame: 0, 6 weeks

    Implicit Attitude Tests assessed using a calculated D score using the method described by Greenwald et al.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Acronym: FL75

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 27, 2011
Registry last updated
Mar 12, 2024

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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