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

About

Brief Summary

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.

Primary Purpose
Other
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
20 Years
Maximum Age
N/A

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.

Join this Trial

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Study Stats
Protocol No.
19-002074
Category
Center for Human Nutrition
Contact
Gail Thames
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04342624
For detailed technical eligibility, visit ClinicalTrials.gov.