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

NCT04342624 | Completed

• 1 other identifier: 19-002074
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Blood Glucose, High

Keywords

glucose; cinnamon; pre-diabetes; microbiome

Outcome Measures

Primary Outcomes (3)

• 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

  3 hours

• 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

  4 weeks

• 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.

  4 weeks

Study Arms (2)

Cinnamon

EXPERIMENTAL

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

Dietary Supplement: Cinnamon

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Cinnamon DIETARY_SUPPLEMENT

Cinnamon supplement

Cinnamon

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Zelicha H, Yang J, Henning SM, Huang J, Lee RP, Thames G, Livingston EH, Heber D, Li Z. Effect of cinnamon spice on continuously monitored glycemic response in adults with prediabetes: a 4-week randomized controlled crossover trial. Am J Clin Nutr. 2024 Mar;119(3):649-657. doi: 10.1016/j.ajcnut.2024.01.008. Epub 2024 Jan 26.

  PMID: 38290699 DERIVED

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Zhaoping Li

  UCLA Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 13, 2020
• Study Start: April 14, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)