Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure.
Subjects will be randomly assigned to a diet. They will at onset have hemoglobin A1c values between 5.7% and 6.4%. Baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. Interim tests will be performed at six weeks. Subjects will participate for 12 weeks, at which time they will be re-evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
48
Diet of food items that have no carrageenan as selected by study dietician.
Diet of food items that have carrageenan as selected by study dietician
University of Illinois at Chicago
Chicago, Illinois, United States
Change in hemoglobin A1c
Measurements performed after 12 weeks of dietary intervention
Time frame: baseline, 12 weeks
Change in serum Interleukin-8
Impact of diet on serum Interleukin-8
Time frame: baseline, 12 weeks
Impact on glucose tolerance test
perform repeat oral glucose tolerance test after 12 weeks of dietary intervention
Time frame: 12 weeks
Impact on insulin level
determine effect of dietary intervention on insulin level at the time of glucose tolerance test
Time frame: 12 weeks
Change in leukocyte subsets
determine if there is change in distribution of leukocyte subsets from blood samples of study participants
Time frame: baseline, 12 weeks
Change in Tumor Necrosis Factor-alpha in serum
determine if there is change in circulating TNF-alpha in blood samples
Time frame: baseline, 12 weeks
Change in insulin signaling pathway
determine if there are changes in activation of intermediates in insulin signaling pathway in circulating leukocytes following dietary intervention
Time frame: baseline, 12 weeks
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