PreDiabetesCINNIINCT04342624
Investigation of Cinnamon Spice on Glucose Tolerance in Subjects With Pre-diabetes
A study testing Cinnamon in people with PreDiabetes and Blood Glucose, High, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Blood Glucose, High
- What is being tested?
- Cinnamon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cinnamon Spice on Glucose, Insulin, GI Hormone and Microbiome in Obese Individuals With Pre-Diabetes
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.
Read the detailed description
Participants will be asked to take cinnamon spice or placebo capsules daily with breakfast and dinner (2 weeks of cinnamon, 2 weeks of placebo). The placebo capsule is a study product that looks like the cinnamon capsules, but contains no active ingredients. The amount of cinnamon will be 4 grams per day. 2 grams will be taken at breakfast and dinner. Timed blood collections over a three-hour period will be used to measure how cinnamon spice affects glucose metabolism/insulin sensitivity in human subjects. Everyone who participates in the study will receive each treatment in random order. In this way, everyone will receive cinnamon spice capsules and placebo.
In a crossover study design subjects will consume either cinnamon or placebo with foods and before bed for 28 days. The placebo capsule is a study product that looks like the cinnamon capsules, but contains no active ingredients. The participants will also be asked to undergo an oral glucose tolerance test 4 times (on separate days) before and after the first and second cinnamon/placebo consumption. Subjects will take 3 capsules of cinnamon or placebo (total 2 g) with the glucose drink (75 g). Timed blood collections over a three-hour period will be used to measure how cinnamon spice affects glucose metabolism/insulin sensitivity in human subject. Continuous glucose monitoring will performed through the entire study for each subject. The microbiome will also be examined at the beginning and end of each 28 day phase (0-4 weeks and 6-10weeks). Subjects will consume a brown-beige diet during the study to exclude the effects of other polyphenol-rich foods. We will enroll twenty subjects >= 20 years of age, overweight/obese (BMI 25 to 35 kg/ m2) with fasting blood sugar between 100 and 126 mg/dl or HbA1c >=5.7% and <= 6.5%.
- Conditions
- PreDiabetes, Blood Glucose, High
- Being tested
- Cinnamon, Placebo
- Keywords
- glucose, cinnamon, pre-diabetes, microbiome
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinnamonDietary supplement
Cinnamon supplement
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon | Experimental | Consume 4g of cinnamon capsules daily. Will be randomized, double blind, cross-over to other arm after. Receives: Dietary Supplement: Cinnamon |
| Placebo | Placebo comparator | Consume 4g of placebo daily. Will be randomized, double blind, cross-over to other arm. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start14 Apr 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, Principal investigator, UCLA Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342624
- Sponsor's protocol ID
- 19-002074
- Acronym
- CINNII
- Status last verified
- May 2023
- First submitted
- 7 Apr 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38290699
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cinnamon Spice on Glucose, Insulin, GI Hormone and Microbiome in Obese Individuals With Pre-Diabetes
- ClinicalTrials.gov ID
- NCT04342624
- Acronym / sponsor ID
- CINNII / 19-002074
- Conditions
- PreDiabetes, Blood Glucose, High
- Keywords
- glucose, cinnamon, pre-diabetes, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be asked to take cinnamon spice or placebo capsules daily with breakfast and dinner (2 weeks of cinnamon, 2 weeks of placebo). The placebo capsule is a study product that looks like the cinnamon capsules, but contains no active ingredients. The amount of cinnamon will be 4 grams per day. 2 grams will be taken at breakfast and dinner. Timed blood collections over a three-hour period will be used to measure how cinnamon spice affects glucose metabolism/insulin sensitivity in human subjects. Everyone who participates in the study will receive each treatment in random order. In this way, everyone will receive cinnamon spice capsules and placebo.
In a crossover study design subjects will consume either cinnamon or placebo with foods and before bed for 28 days. The placebo capsule is a study product that looks like the cinnamon capsules, but contains no active ingredients. The participants will also be asked to undergo an oral glucose tolerance test 4 times (on separate days) before and after the first and second cinnamon/placebo consumption. Subjects will take 3 capsules of cinnamon or placebo (total 2 g) with the glucose drink (75 g). Timed blood collections over a three-hour period will be used to measure how cinnamon spice affects glucose metabolism/insulin sensitivity in human subject. Continuous glucose monitoring will performed through the entire study for each subject. The microbiome will also be examined at the beginning and end of each 28 day phase (0-4 weeks and 6-10weeks). Subjects will consume a brown-beige diet during the study to exclude the effects of other polyphenol-rich foods. We will enroll twenty subjects >= 20 years of age, overweight/obese (BMI 25 to 35 kg/ m2) with fasting blood sugar between 100 and 126 mg/dl or HbA1c >=5.7% and <= 6.5%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon | Experimental | Dietary Supplement: CinnamonConsume 4g of cinnamon capsules daily. Will be randomized, double blind, cross-over to other arm after. |
| Placebo | Placebo comparator | Other: PlaceboConsume 4g of placebo daily. Will be randomized, double blind, cross-over to other arm. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CinnamonCinnamon supplement | Dietary supplement | Cinnamon |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Blood glucose control using glucose tolerance test
Time frame: 3 hours
To determine the effect of cinnamon on glucose tolerance acutely after 75g glucose intake in pre-diabetic overweight/obese individuals
Blood glucose control with continuous glucose monitoring.
Time frame: 4 weeks
To determine the effect of cinnamon on glucose tolerance for 4 weeks in pre-diabetic overweight/obese individuals
Mircobiome effects of cinnamon through stool sample collection
Time frame: 4 weeks
To determine the effects of cinnamon on gut microbiota, short chain fatty acids, gut hormones GLP-1, GIP,glucagon and metabolomics.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 38290699Zelicha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li principal investigator
UCLA Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinnamon in people with PreDiabetes and Blood Glucose, High, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose control using glucose tolerance test (time frame: 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.