PreDiabetes Clinical Trial
— CINNIIOfficial title:
Effects of Cinnamon Spice on Glucose, Insulin, GI Hormone and Microbiome in Obese Individuals With Pre-Diabetes
Verified date | May 2023 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Healthy human adults age >=20 years' old - Typically consume low fiber/polyphenol diet (beige diet see below) - Overweight/obese individuals with a BMI of 25 to 40 kg/m2 and HbA1c >=5.6% and <= 6.5%. - Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent. Exclusion Criteria: - Any subjects with cinnamon intolerance - Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator. - Any subject currently taking blood thinning medications such as Warfarin or Coumadin - Any history of gastrointestinal disease or surgery except for appendectomy or cholecystectomy. - Eating a high fiber/polyphenol diet or taking any medication or dietary supplement, which interfere with the absorption of polyphenols. - History of gastrointestinal surgery, diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP >160mmHg, diastolic BP >95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history. - Pregnant or breastfeeding - Currently uses tobacco products. - Currently has an alcohol intake >= 20 g / day; - Currently has a coffee intake >= 3 cups / day; - Allergy or sensitivity to cinnamon. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive history of cinnamon ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded - Is unable or unwilling to comply with the study protocol. |
Country | Name | City | State |
---|---|---|---|
United States | UCLA | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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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