Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01403857
Study type Interventional
Source USDA, Western Human Nutrition Research Center
Contact
Status Completed
Phase N/A
Start date April 2010
Completion date December 2013

See also
  Status Clinical Trial Phase
Completed NCT03003923 - Promoting Vegetable Intake in Preschool Aged Children N/A
Completed NCT03113474 - Profiling the Endocannabinoid Response to Hedonic Eating N/A
Recruiting NCT04662606 - Neurofunctional Correlates of Intentional Actions Towards Food Stimuli N/A
Recruiting NCT06015490 - The Impact of the Physiological Response to Sugar on Brain Activity and Behavior N/A
Recruiting NCT05652842 - Assessing the Impact of Rotational and Shift Work on Sleep, Activity, Energy Balance, and Food Choice in Adults
Completed NCT05079477 - Online Study of the Effects of Sugary Drink Warning Labels on Consumption N/A
Recruiting NCT05977348 - Increasing Food Literacy in Preschoolers to Reduce Obesity Risk N/A
Completed NCT04544332 - The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
Completed NCT04497974 - Sweet Tooth: Nature or Nurture? Role of Long-term Dietary Sweetness Exposure on Sweetness Preferences N/A
Completed NCT03400566 - Effects of Experiential Learning on Vegetable Intake in Preschool Children N/A
Active, not recruiting NCT04262102 - The Dastatuz Project N/A
Completed NCT05592340 - Restaurant Menu Carbon Footprint Labeling N/A
Recruiting NCT02005003 - Cognitive and Metabolic Effects of a Probiotic Supplement N/A
Completed NCT05432271 - Online Food and Beverage Labels and Vending Machine Selections N/A
Active, not recruiting NCT04788836 - How Altered Gut-Brain-Axis Influences Food Choices: Part 2 (BrainFood)
Completed NCT05175391 - Improving Protein Intake in Older Adults N/A
Not yet recruiting NCT06324630 - Implementation of Innovative Food Prescription Programs in Older Adults N/A
Recruiting NCT02931812 - Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation
Completed NCT02457234 - Influence of Cultural Immersion on Willingness to Try Fruits and Vegetables Among Children in Guam: the Traditions Study N/A
Recruiting NCT06432517 - Sources and Mechanisms of Energy Compensation N/A