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Completed

NCT Number: NCT04686552

Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses

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

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cinnamon

Dietary Supplement

6 g of ground cinnamon

Other names: control

Primary outcomes

  1. glucose

    Time frame: Baseline to 180 minutes

    postprandial glucose reponse

  2. insulin

    Time frame: Baseline to 180 minutes

    postprandial insulin response

Secondary outcomes

  1. C-peptide

    Time frame: Baseline to 180 minutes

    postprandial C-peptide response

  2. glucagon

    Time frame: Baseline to 180 minutes

    postprandial glucagon reponse

  3. lipids

    Time frame: Baseline to 180 minutes

    postprandial lipid response

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Acronym: CINNI

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 28, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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