Investigation of Cinnamon Spice on Glucose Tolerance in Subjects With Pre-diabetes (CINNII)
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|ClinicalTrials.gov Identifier: NCT04342624|
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : April 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes Blood Glucose, High||Dietary Supplement: Cinnamon Other: Placebo||Not Applicable|
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%.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Cinnamon Spice on Glucose, Insulin, GI Hormone and Microbiome in Obese Individuals With Pre-Diabetes|
|Actual Study Start Date :||April 14, 2021|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
Consume 4g of cinnamon capsules daily. Will be randomized, double blind, cross-over to other arm after.
Dietary Supplement: Cinnamon
Placebo Comparator: Placebo
Consume 4g of placebo daily. Will be randomized, double blind, cross-over to other arm.
- Blood glucose control using glucose tolerance test [ Time Frame: 3 hours ]To determine the effect of cinnamon on glucose tolerance acutely after 75g glucose intake in pre-diabetic overweight/obese individuals
- Blood glucose control with continuous glucose monitoring. [ Time Frame: 4 weeks ]To determine the effect of cinnamon on glucose tolerance for 4 weeks in pre-diabetic overweight/obese individuals
- Mircobiome effects of cinnamon through stool sample collection [ Time Frame: 4 weeks ]To determine the effects of cinnamon on gut microbiota, short chain fatty acids, gut hormones GLP-1, GIP,glucagon and metabolomics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342624
|Contact: Gail Thamesemail@example.com|
|Contact: Dina Ben-Nissan||310-206-2582||Dbennissan@mednet.ucla.edu|
|Principal Investigator:||Zhaoping Li||UCLA Professor of Medicine|