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This study aims to determine whether the effectiveness of cinnamon spice capsules vs. placebo capsules on glucose tolerance in prediabetic subjects who are overweight or obese.
Participants will be asked to take cinnamon spice or placebo capsules daily with breakfast and dinner (2 weeks of cinnamon, 2 weeks of placebo). The placebo capsule is a study product that looks like the cinnamon capsules, but contains no active ingredients. The amount of cinnamon will be 4 grams per day. 2 grams will be taken at breakfast and dinner. Timed blood collections over a three-hour period will be used to measure how cinnamon spice affects glucose metabolism/insulin sensitivity in human subjects. Everyone who participates in the study will receive each treatment in random order. In this way, everyone will receive cinnamon spice capsules and placebo.
In a crossover study design subjects will consume either cinnamon or placebo with foods and before bed for 28 days. The placebo capsule is a study product that looks like the cinnamon capsules, but contains no active ingredients. The participants will also be asked to undergo an oral glucose tolerance test 4 times (on separate days) before and after the first and second cinnamon/placebo consumption. Subjects will take 3 capsules of cinnamon or placebo (total 2 g) with the glucose drink (75 g). Timed blood collections over a three-hour period will be used to measure how cinnamon spice affects glucose metabolism/insulin sensitivity in human subject. Continuous glucose monitoring will performed through the entire study for each subject. The microbiome will also be examined at the beginning and end of each 28 day phase (0-4 weeks and 6-10weeks). Subjects will consume a brown-beige diet during the study to exclude the effects of other polyphenol-rich foods. We will enroll twenty subjects >= 20 years of age, overweight/obese (BMI 25 to 35 kg/ m2) with fasting blood sugar between 100 and 126 mg/dl or HbA1c >=5.7% and <= 6.5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinnamon | Experimental | Consume 4g of cinnamon capsules daily. Will be randomized, double blind, cross-over to other arm after. |
|
| Placebo | Placebo Comparator | Consume 4g of placebo daily. Will be randomized, double blind, cross-over to other arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinnamon | Dietary Supplement | Cinnamon supplement |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose control using glucose tolerance test | To determine the effect of cinnamon on glucose tolerance acutely after 75g glucose intake in pre-diabetic overweight/obese individuals | 3 hours |
| Blood glucose control with continuous glucose monitoring. | To determine the effect of cinnamon on glucose tolerance for 4 weeks in pre-diabetic overweight/obese individuals | 4 weeks |
| Mircobiome effects of cinnamon through stool sample collection | To determine the effects of cinnamon on gut microbiota, short chain fatty acids, gut hormones GLP-1, GIP,glucagon and metabolomics. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li | UCLA Professor of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38290699 | Derived | Zelicha H, Yang J, Henning SM, Huang J, Lee RP, Thames G, Livingston EH, Heber D, Li Z. Effect of cinnamon spice on continuously monitored glycemic response in adults with prediabetes: a 4-week randomized controlled crossover trial. Am J Clin Nutr. 2024 Mar;119(3):649-657. doi: 10.1016/j.ajcnut.2024.01.008. Epub 2024 Jan 26. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Other |
Placebo |
|
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |