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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04686552
Other study ID # 18-000464
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 1, 2020

Study information

Verified date December 2020
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 1, 2020
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
cinnamon
6 g of ground cinnamon

Locations

Country Name City State
United States UCLA Center for Human Nutrition Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary glucose postprandial glucose reponse Baseline to 180 minutes
Primary insulin postprandial insulin response Baseline to 180 minutes
Secondary C-peptide postprandial C-peptide response Baseline to 180 minutes
Secondary glucagon postprandial glucagon reponse Baseline to 180 minutes
Secondary lipids postprandial lipid response Baseline to 180 minutes
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