8,000
Participants
Start Date
April 14, 2023
Primary Completion Date
December 31, 2026
Study Completion Date
January 31, 2027
Diet A
This diet has high amounts of fruits/vegetables, whole grains, and beans, moderate amounts of dairy, meat/poultry/eggs, nuts/seeds, and olive oil, and very low amounts of sugar sweetened drinks and desserts. Menus are developed for 1600kcal, 2100kcal, 2600kcal, 3200 kcal and 3700 kcal.
Diet B
This diet has high amounts of refined grains, meat/poultry/egg, sugar sweetened drinks, snacks, desserts, and processed foods. It has a moderate amount of dairy and low amounts of fruits/vegetables, whole grains, and fish. Menus are developed for 1600kcal, 2100kcal, 2600kcal, 3200 kcal and 3700 kcal.
Diet C
This diet has moderate-high amounts of vegetables, meat/poultry/egg, nuts/seeds, dairy and fats/oils, low amounts of fruits, and very low amounts of grains and sugars. Menus are developed for 1600kcal, 2100kcal, 2600kcal, 3200 kcal and 3700 kcal.
Liquid Mixed Meal Tolerance Test
A liquid mixed meal tolerance test will occur in Module 1 and Module 3. For this test, participants will drink two servings of Ensure® Original, vanilla flavor. The meal will also contain acetaminophen (Tylenol) which will show how the smoothie moves through the participant's gut.
Diet-Specific Mixed Meal Tolerance Test
The diet-specific mixed meal tolerance test is administered at the end of each dietary intervention period in Modules 2 and 3. The meal test is a breakfast meal similar to the one eaten on the 14-day diets. Thus, three test meals will be used, one for each of the three test diets (Diet A, Diet B, Diet C). The energy (kcal) level of the breakfast meal will be based on each participant's diet prescription. The nutritional composition diet-specific MMTT will be the same test meal for all participants.
RECRUITING
University of North Carolina at Chapel Hill - Chapel Hill Clinic, Chapel Hill
RECRUITING
University of North Carolina at Chapel Hill - Kannapolis, Kannapolis
RECRUITING
University of Alabama at Birmingham, Birmingham
RECRUITING
Northwestern University, Chicago
RECRUITING
Illinois Institute of Technology, Chicago
RECRUITING
University of Chicago, Chicago
RECRUITING
Louisiana State University Health Sciences Center, New Orleans
RECRUITING
Pennington Biomedical Research Center, Baton Rouge
RECRUITING
University of California, Los Angeles, Los Angeles
RECRUITING
Cedars Sinai Medical Center, West Hollywood
RECRUITING
USDA Western Human Nutrition Research Center, Davis
RECRUITING
University of California, Davis, Sacramento
RECRUITING
Tufts University, Boston
RECRUITING
Massachusetts General Hospital, Boston
Collaborators (3)
National Institutes of Health (NIH)
NIH
University of North Carolina, Chapel Hill
OTHER
Northwestern University
OTHER
Illinois Institute of Technology
OTHER
University of Chicago
OTHER
Pennington Biomedical Research Center
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
University of California, Davis
OTHER
University of California, Los Angeles
OTHER
Cedars-Sinai Medical Center
OTHER
University of Alabama at Birmingham
OTHER
Tufts University
OTHER
Massachusetts General Hospital
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
National Cancer Institute (NCI)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
City University of New York, School of Public Health
OTHER
Mayo Clinic
OTHER
University of California, San Diego
OTHER
University of Hawaii
OTHER
Vanderbilt University Medical Center
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institute of Drug Abuse
FED
Public Health Informatics Computational and Operations Research
UNKNOWN
University of Southern California
OTHER
Cornell University
OTHER
University of Alabama, Tuscaloosa
OTHER
North Carolina State University
OTHER
University of North Carolina, Charlotte
OTHER
Duke University
OTHER
Stevens Institute of Technology
OTHER
Purdue University
OTHER
United States Military Academy West Point
FED
USDA, Western Human Nutrition Research Center
FED
North Carolina Central University
OTHER
Wake Forest University Health Sciences
OTHER
Boston University
OTHER
Children's Hospital of Richmond
UNKNOWN
Virginia Commonwealth University
OTHER
Verily Life Sciences LLC
INDUSTRY
Indiana University
OTHER
Fred Hutchinson Cancer Center
OTHER
Columbia University
OTHER
University of Pennsylvania
OTHER
RTI International
OTHER