Investigation of Cinnamon Spice on Glucose Tolerance in Subjects With Pre-diabetes
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.
- 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.
- 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.