Normal WeightCINNINCT04686552
Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses
A study testing cinnamon in people with Normal Weight and Overweight and Obesity, run by University of California, Los Angeles at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Weight, Overweight and Obesity
- What is being tested?
- cinnamon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Jan 2020
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition
Los Angeles, California, 90024
About this study
Official title: Effects of Cinnamon Spice on Postprandial Glucose and Insulin in Normal Weight and Obese Individuals With Pre-Diabetes: A Pilot Study
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
Read the detailed 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.
- Conditions
- Normal Weight, Overweight and Obesity
- Being tested
- cinnamon
- Keywords
- cinnamon, insulin, glucose, postprandial, acute
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinnamonDietary supplement
Also called control
6 g of ground cinnamon
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose
postprandial glucose reponse
Measured: Baseline to 180 minutes
insulin
postprandial insulin response
Measured: Baseline to 180 minutes
Secondary outcomes (3)
C-peptide
postprandial C-peptide response
Measured: Baseline to 180 minutes
glucagon
postprandial glucagon reponse
Measured: Baseline to 180 minutes
lipids
postprandial lipid response
Measured: Baseline to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2020
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 Normal WeightStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 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, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686552
- Sponsor's protocol ID
- 18-000464
- Acronym
- CINNI
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33553233
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cinnamon Spice on Postprandial Glucose and Insulin in Normal Weight and Obese Individuals With Pre-Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT04686552
- Acronym / sponsor ID
- CINNI / 18-000464
- Conditions
- Normal Weight, Overweight and Obesity
- Keywords
- cinnamon, insulin, glucose, postprandial, acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 28 Dec 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.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cinnamon | Experimental | Dietary Supplement: cinnamonThe test meal consisted of ½ cup dry instant oatmeal, prepared with 1 cup of 2% milk served with 6 g of ground 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| cinnamonAlso: control6 g of ground cinnamon | Dietary supplement | cinnamon |
Primary outcome
glucose
Time frame: Baseline to 180 minutes
postprandial glucose reponse
insulin
Time frame: Baseline to 180 minutes
postprandial insulin response
3 secondary outcomes
C-peptide
Time frame: Baseline to 180 minutes
glucagon
Time frame: Baseline to 180 minutes
lipids
Time frame: Baseline to 180 minutes
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 28 Dec 2020.
- Derived from this study: PubMed 33553233Wang 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.
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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, MD, PhD principal investigator
University of California, Los Angeles
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 Normal Weight and Overweight and Obesity, 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 5 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 28 Dec 2020. 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. 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?
glucose (time frame: Baseline to 180 minutes). The study lists 2 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 NCT04686552, 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 28 Dec 2020; AzTrials last refreshed its copy on 2 Nov 2026.