Evaluating Liking, Acceptability and Health Benefits of Grain Products (FL75)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01403857
First received: July 5, 2011
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

The specific aims of the Grain Study are to determine if sensitivity to bitter taste affects the liking and acceptability of different grain products, 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.


Condition Intervention
Food Preferences
Other: Whole grain foods
Other: Refined grains

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluating Liking, Acceptability and Health Benefits of Grain Products

Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in the acceptability and liking of grain products [ Time Frame: 0, 6, 26, and 52 weeks ] [ Designated as safety issue: No ]
    Sensory evaluation of grain products

  • Change in the gut microbiota and their fermentation products [ Time Frame: 0, 6, 26, and 52 weeks ] [ Designated as safety issue: No ]
    To determine if gut microbiota change over the intervention and if those changes persist over the long term.


Secondary Outcome Measures:
  • Change in gastrointestinal function [ Time Frame: 0, 6 weeks ] [ Designated as safety issue: No ]
    Does increased consumption of whole grain products improve gastrointestinal function?


Enrollment: 45
Study Start Date: April 2010
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole Grain
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
Eight commonly consumed whole grain products that meet the consumers Dietary Guidelines recommendations for a period of six weeks.
Placebo Comparator: Refined Grains
Time control compared to experimental intervention.
Other: Refined grains
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.

Detailed Description:

Subjects will be recruited in accordance with inclusion and exclusion criteria listed below. During the screening process sensitivity to n-propyl-thiouracil (PROP) will be evaluated to classify subjects as "non-tasters", "tasters", and "supertasters".

Subjects within each PROP class 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 50% of grain intake for the WG group (this is the current Dietary Guideline recommendation) 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. Follow-up visits at 26 and 52 weeks, post-intervention, will be scheduled with all subjects to re-evaluate acceptability, liking, and other variables related to whole grain intake.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01403857

Locations
United States, California
Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Nancy Keim, PhD USDA, Western Human Nutrition Research Center
Study Director: William Horn, MS USDA, Western Human Nutrition Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01403857     History of Changes
Other Study ID Numbers: WHNRC 235561-1
Study First Received: July 5, 2011
Last Updated: April 21, 2014
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
Acceptability
liking

ClinicalTrials.gov processed this record on September 18, 2014