Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses

NCT04686552 | Completed

• 1 other identifier: 18-000464
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Normal Weight; Overweight and Obesity

Keywords

cinnamon; insulin; glucose; postprandial; acute

Outcome Measures

Primary Outcomes (2)

• glucose

  postprandial glucose reponse

  Baseline to 180 minutes

• insulin

  postprandial insulin response

  Baseline to 180 minutes

Secondary Outcomes (3)

• C-peptide

  Baseline to 180 minutes

• glucagon

  Baseline to 180 minutes

• lipids

  Baseline to 180 minutes

Study Arms (2)

cinnamon

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

cinnamon DIETARY_SUPPLEMENT

6 g of ground cinnamon

Also known as: control

cinnamon

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

Location

Related Publications (1)

• 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.

  PMID: 33553233 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

US (1)