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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
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
PreDiabetes Blood Glucose, High Dietary Supplement: Cinnamon Other: Placebo Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Cinnamon
Consume 4g of cinnamon capsules daily. Will be randomized, double blind, cross-over to other arm after.
Dietary Supplement: Cinnamon
Cinnamon supplement

Placebo Comparator: Placebo
Consume 4g of placebo daily. Will be randomized, double blind, cross-over to other arm.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Gail Thames 310-825-0453 gthames@mednet.ucla.edu
Contact: Dina Ben-Nissan 310-206-2582 Dbennissan@mednet.ucla.edu

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Gail Thames    310-825-0453    gthames@mednet.ucla.edu   
Contact: Dina Ben-Nissan    310-206-2582    dbennissan@mednet.ucla.edu   
Principal Investigator: Zhaoping Li         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Zhaoping Li UCLA Professor of Medicine
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Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04342624    
Other Study ID Numbers: 19-002074
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaoping Li, University of California, Los Angeles:
glucose
cinnamon
pre-diabetes
microbiome
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Hyperglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases