Prediabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo-carrageenan diet
Diet of food items that have no carrageenan as selected by study dietician.
OTHERRegular Diet
Diet of food items that have carrageenan as selected by study dietician
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* per diabetes, ability to follow diet and study procedures
Exclusion criteria
* on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin A1c | baseline, 12 weeks | Measurements performed after 12 weeks of dietary intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on insulin level | 12 weeks | determine effect of dietary intervention on insulin level at the time of glucose tolerance test |
| Change in serum Interleukin-8 | baseline, 12 weeks | Impact of diet on serum Interleukin-8 |
| Impact on glucose tolerance test | 12 weeks | perform repeat oral glucose tolerance test after 12 weeks of dietary intervention |
| Change in Tumor Necrosis Factor-alpha in serum | baseline, 12 weeks | determine if there is change in circulating TNF-alpha in blood samples |
| Change in insulin signaling pathway | baseline, 12 weeks | determine if there are changes in activation of intermediates in insulin signaling pathway in circulating leukocytes following dietary intervention |
| Change in leukocyte subsets | baseline, 12 weeks | determine if there is change in distribution of leukocyte subsets from blood samples of study participants |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal microbiome | baseline, 12 weeks | Impact of diet on fecal microbiome following dietary intervention determined by whole genome sequencing of fecal bacteria |
| Change in fecal calprotectin | baseline, 12 weeks | determine effect of dietary intervention on fecal calprotectin |
Countries
United States
Outcome results
None listed