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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular diet | Placebo Comparator | Meals and snacks will contain carrageenan in the amount consumed in the typical daily diet and will be selected by the study dietician and distributed to study subjects randomized to the regular diet study arm. |
|
| No-carrageenan diet | Experimental | No-carrageenan diet will be composed of meals and snacks selected by the study dietician and distributed to study participants who are randomized to the no-carrageenan diet study arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No-carrageenan diet | Other | Diet of food items that have no carrageenan as selected by study dietician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin A1c | Measurements performed after 12 weeks of dietary intervention | baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum Interleukin-8 | Impact of diet on serum Interleukin-8 | baseline, 12 weeks |
| Impact on glucose tolerance test | perform repeat oral glucose tolerance test after 12 weeks of dietary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal microbiome | Impact of diet on fecal microbiome following dietary intervention determined by whole genome sequencing of fecal bacteria | baseline, 12 weeks |
| Change in fecal calprotectin | determine effect of dietary intervention on fecal calprotectin |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
If required, individual data without identifiers may be made available.
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Regular Diet | Other | Diet of food items that have carrageenan as selected by study dietician |
|
|
| 12 weeks |
| Impact on insulin level | determine effect of dietary intervention on insulin level at the time of glucose tolerance test | 12 weeks |
| Change in leukocyte subsets | determine if there is change in distribution of leukocyte subsets from blood samples of study participants | baseline, 12 weeks |
| Change in Tumor Necrosis Factor-alpha in serum | determine if there is change in circulating TNF-alpha in blood samples | 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 | baseline, 12 weeks |
| baseline, 12 weeks |
| D004700 | Endocrine System Diseases |