Evaluating Liking, Acceptability and Health Benefits of Grain Products

Food Preferences Clinical Trial

— FL75  

Official title:

Evaluating Liking, Acceptability and Health Benefits of Grain Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403857
• Other study ID #: WHNRC 235561-1
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2024
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Preferences

Intervention

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

Locations

Country	Name	City	State
United States	Western Human Nutrition Research Center	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View Citation

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. — View Citation

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 N — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the acceptability and liking of grain products	Sensory evaluation of grain products	0, 6 weeks
Primary	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	Change in gastrointestinal function	Change in gastrointestinal function assessed using a questionnaire and exhaled breath hydrogen (ppm).	0, 6 weeks
Secondary	Liking the taste of grain products	Implicit Attitude Tests assessed using a calculated D score using the method described by Greenwald et al.	0, 6 weeks

External Links

•   Western Human Nutrition Research Center website