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

Primary Purpose

PreDiabetes, Blood Glucose, High

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cinnamon

Placebo

About this trial

This is an interventional other trial for PreDiabetes focused on measuring glucose, cinnamon, pre-diabetes, microbiome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cinnamon

Placebo

Arm Description

Consume 4g of cinnamon capsules daily. Will be randomized, double blind, cross-over to other arm after.

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

Outcomes

Primary Outcome Measures

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04342624

First Posted

April 7, 2020

Last Updated

May 4, 2023

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT04342624

Brief Title

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

Acronym

CINNII

Official Title

Effects of Cinnamon Spice on Glucose, Insulin, GI Hormone and Microbiome in Obese Individuals With Pre-Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 14, 2021 (Actual)

Primary Completion Date

January 1, 2023 (Actual)

Study Completion Date

January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PreDiabetes, Blood Glucose, High

Keywords

glucose, cinnamon, pre-diabetes, microbiome

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cinnamon

Arm Type

Experimental

Arm Description

Consume 4g of cinnamon capsules daily. Will be randomized, double blind, cross-over to other arm after.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Cinnamon

Intervention Description

Cinnamon supplement

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Blood glucose control using glucose tolerance test

Description

To determine the effect of cinnamon on glucose tolerance acutely after 75g glucose intake in pre-diabetic overweight/obese individuals

Time Frame

3 hours

Title

Blood glucose control with continuous glucose monitoring.

Description

To determine the effect of cinnamon on glucose tolerance for 4 weeks in pre-diabetic overweight/obese individuals

Time Frame

4 weeks

Title

Mircobiome effects of cinnamon through stool sample collection

Description

To determine the effects of cinnamon on gut microbiota, short chain fatty acids, gut hormones GLP-1, GIP,glucagon and metabolomics.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoping Li

Organizational Affiliation

UCLA Professor of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

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

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