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Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses (CINNI)

Primary Purpose

Normal Weight, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cinnamon
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Weight focused on measuring cinnamon, insulin, glucose, postprandial, acute

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy human adults age 20-50 years' old
  • Typically consume low fiber/polyphenol diet (beige diet)
  • normal weight individuals with a BMI of 18. to 24.9 kg/ m2 with fasting serum glucose <100 mg/dL
  • overweight/obese individuals with a BMI of 25 to 35 kg/m2 and fasting serum glucose ≥100 mg/dL and <126 mg/dL or HbA1c >5.7% 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 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, 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 lactose intolerant
  • Is unable or unwilling to comply with the study protocol.

Sites / Locations

  • UCLA Center for Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cinnamon

control

Arm Description

The test meal consisted of ½ cup dry instant oatmeal, prepared with 1 cup of 2% milk served with 6 g of ground cinnamon.

The test meal consisted of ½ cup dry instant oatmeal, prepared with 1 cup of 2% milk served without 6 g of ground cinnamon

Outcomes

Primary Outcome Measures

glucose
postprandial glucose reponse
insulin
postprandial insulin response

Secondary Outcome Measures

C-peptide
postprandial C-peptide response
glucagon
postprandial glucagon reponse
lipids
postprandial lipid response

Full Information

First Posted
December 21, 2020
Last Updated
December 24, 2020
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04686552
Brief Title
Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses
Acronym
CINNI
Official Title
Effects of Cinnamon Spice on Postprandial Glucose and Insulin in Normal Weight and Obese Individuals With Pre-Diabetes: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the proposed study is to investigate the effect of cinnamon on the postprandial glycemic response to a high glycemic index meal in normal and overweight/obese prediabetic subjects
Detailed Description
A randomized crossover study design will be carried out in accordance with the guidelines of the Human Subjects Protection Committee of the University of California, Los Angeles. All subjects will give written informed consent before the study begins. There will be two groups of participants (normal and overweight/obese). Each participant will consume oatmeal prepared with 1 cup of 2% milk served with or without 6 g of ground cinnamon in random sequence. At each meal consumption blood will be collected to measure postprandial glucose and insulin at 0, 30, 60, 90, 120, 150 and 180 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Weight, Overweight and Obesity
Keywords
cinnamon, insulin, glucose, postprandial, acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cinnamon
Arm Type
Experimental
Arm Description
The test meal consisted of ½ cup dry instant oatmeal, prepared with 1 cup of 2% milk served with 6 g of ground cinnamon.
Arm Title
control
Arm Type
No Intervention
Arm Description
The test meal consisted of ½ cup dry instant oatmeal, prepared with 1 cup of 2% milk served without 6 g of ground cinnamon
Intervention Type
Dietary Supplement
Intervention Name(s)
cinnamon
Other Intervention Name(s)
control
Intervention Description
6 g of ground cinnamon
Primary Outcome Measure Information:
Title
glucose
Description
postprandial glucose reponse
Time Frame
Baseline to 180 minutes
Title
insulin
Description
postprandial insulin response
Time Frame
Baseline to 180 minutes
Secondary Outcome Measure Information:
Title
C-peptide
Description
postprandial C-peptide response
Time Frame
Baseline to 180 minutes
Title
glucagon
Description
postprandial glucagon reponse
Time Frame
Baseline to 180 minutes
Title
lipids
Description
postprandial lipid response
Time Frame
Baseline to 180 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy human adults age 20-50 years' old Typically consume low fiber/polyphenol diet (beige diet) normal weight individuals with a BMI of 18. to 24.9 kg/ m2 with fasting serum glucose <100 mg/dL overweight/obese individuals with a BMI of 25 to 35 kg/m2 and fasting serum glucose ≥100 mg/dL and <126 mg/dL or HbA1c >5.7% 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 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, 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 lactose intolerant Is unable or unwilling to comply with the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoping Li, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Human Nutrition
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33553233
Citation
Wang J, Wang S, Yang J, Henning SM, Ezzat-Zadeh Z, Woo SL, Qin T, Pan Y, Tseng CH, Heber D, Li Z. Acute Effects of Cinnamon Spice on Post-prandial Glucose and Insulin in Normal Weight and Overweight/Obese Subjects: A Pilot Study. Front Nutr. 2021 Jan 21;7:619782. doi: 10.3389/fnut.2020.619782. eCollection 2020.
Results Reference
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Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses

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