CINNI: Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT04686552

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Normal Weight Overweight and Obesity	Dietary Supplement: cinnamon	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Cinnamon Spice on Postprandial Glucose and Insulin in Normal Weight and Obese Individuals With Pre-Diabetes: A Pilot Study

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cinnamon The test meal consisted of ½ cup dry instant oatmeal, prepared with 1 cup of 2% milk served with 6 g of ground cinnamon.	Dietary Supplement: cinnamon 6 g of ground cinnamon Other Names: control
No Intervention: control The test meal consisted of ½ cup dry instant oatmeal, prepared with 1 cup of 2% milk served without 6 g of ground cinnamon

Arm

Intervention/Treatment

Experimental: cinnamon

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

Dietary Supplement: cinnamon

6 g of ground cinnamon

Other Names:

control

No Intervention: control

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

Outcome Measures

Primary Outcome Measures

glucose [Baseline to 180 minutes]
postprandial glucose reponse
insulin [Baseline to 180 minutes]
postprandial insulin response

Secondary Outcome Measures

C-peptide [Baseline to 180 minutes]
postprandial C-peptide response
glucagon [Baseline to 180 minutes]
postprandial glucagon reponse
lipids [Baseline to 180 minutes]
postprandial lipid response

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.