DysglycemiaPhase 2CinnamonNCT03219411
Effects of Cinnamon Supplementation on Glucose Metabolism in Patients With Pre-diabetes
A Phase 2 study testing Cinnamon in people with Dysglycemia and Obesity, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The transition from normal glucose tolerance to overt type 2 diabetes mellitus (T2D) encompasses a variety of glycemic abnormalities that are commonly referred to as 'prediabetes'. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Dysglycemia, Obesity
- 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 30 Jul 2019
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 20 - 70 years old at screening
- Meet at least one of the following criteria of Prediabetes according to the 2016 American Diabetes Association criteria:
- Impaired Fasting Glucose (IFG [100-125 mg/dL])
- Impaired Glucose Tolerance (IGT [2-h plasma glucose: 140-199 mg/dL based on 75-g OGTT])
- HbA1c between 5.7-6.4%
- Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
Who cannot join
- Documented diabetes mellitus diagnosed by a physician and confirmed by other clinical data.
- Previous use of any antidiabetic medication.
- Cardiovascular disease within 6 months of the study commencement including arrhythmia, congestive heart failure, myocardial infarction or pacemaker placement.
- History of uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg on three or more assessments on more than 1 day). If the patient is on blood pressure medications, dosing should be stable for at least 4 weeks prior to randomization.
- Cancer diagnosis requiring treatment in the past 5 years
- Chronic kidney disease stage 3-5 (estimated glomerular filtration rate < 60; based on MDRD formula or creatinine ≥ 1.4 for men or >1.3 mg/dL for women, or a urine protein ≥ 2+)
Show all 24Show fewer
- Known liver disease or elevation of AST, ALT, or GGT > 2.50 × upper limit of normal at screening.
- Other gastrointestinal diseases (including pancreatitis and inflammatory bowel disease)
- Participation in other clinical trials within 2 months.
- Surgery within 30 days prior to screening.
- Pulmonary disease with dependence on oxygen or daily use of bronchodilators.
- Chronic infections (e.g., human immune-deficiency virus (HIV) or active tuberculosis)
- Allergy or hypersensitivity to any of the ingredients in the test products.
- Cognitive impairment or any other reason to expect the patient would have difficulty complying with study protocol
- Excessive alcohol intake defined as greater than 3 units of alcohol per day.
- Use of weight loss drugs (e.g., lorcaserin [Belviq]; phentermine/topiramate [Qsymia], liraglutide [Saxenda], Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanol-amine], or similar over-the-counter medications) within 3 months of the screening visit.
- Intentional weight loss of ≥ 10 lbs in the previous 6 months.
- Use of dietary supplements that may have glucose-lowering effects (e.g. Sesame, Polygonatum odoratum, Chromium, Vanadium).
- Concurrent enrollment in a weight loss program, such as Weight Watchers.
- Other endocrine disorders affecting glucose metabolism including Cushing' syndrome, acromegaly, hyperthyroidism, hypothyroidism or adrenal insufficiency.
- Fasting plasma triglyceride >500 mg/dl.
- Oral corticosteroids within 3 months.
- Pregnancy and/ or Lactation: Women of childbearing potential will be required to have a negative urine pregnancy test and to use contraception measures during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Moderate anemia, defined as hemoglobin <10.9 in both men and women based on WHO criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-National, Double-Blind, Randomized Trial Of The Influence Of Cinnamon Powders In Subjects With Risk For Developing Diabetes
The transition from normal glucose tolerance to overt type 2 diabetes mellitus (T2D) encompasses a variety of glycemic abnormalities that are commonly referred to as 'prediabetes'. While intensive lifestyle interventions are the cornerstone of T2D prevention, developing safe, cost-effective adjunct therapeutic strategies is a clinically relevant goal. Cinnamon supplementation has been shown to improve fasting plasma glucose in patients with T2D. This placebo-controlled, randomized study will determine if cinnamon improves glucose homeostasis in patients with prediabetes over a 12-week period.
Read the detailed description
BACKGROUND: The transition from normal glucose tolerance and insulin sensitivity to overt type 2 diabetes (T2D) encompasses a variety of glycemic abnormalities that are commonly referred to as 'prediabetes'. In 2003, 314 million people (8.2% of the adult population) had prediabetes, and this number is projected to increase to 472 million (9.0% of the adult population) by 2025. Approximately 40-50% of individuals with prediabetes have been reported to develop T2D within 10 years.
While intensive lifestyle interventions remain the cornerstone of T2D prevention, targeted pharmacotherapy has been shown to be effective and may be considered in high-risk patients. Several antidiabetic medications prevent or, at least, delay the progression from prediabetes to diabetes, including metformin, α-glucosidase inhibitors or pioglitazone. However, cost, potential adverse effects, and secondary failure in the long-term have often limited the widespread use of these and other newer antidiabetic drugs in patients with prediabetes. For instance 10 to 20% of metformin-treated patients experience gastrointestinal side effects (nausea, vomiting, and diarrhea) leading to its discontinuation, whereas the use pioglitazone is often complicated by weight gain and increased risk of fractures.
In this context, efficacious, cost-effective, and safe adjunct therapeutics for T2D prevention are highly desirable. The present trial proposes to test the effects of cinnamon in patients with prediabetes.
RATIONALE: Several randomized controlled studies have addressed the effects of cinnamon on changes in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) in adult patients with T2D. Almost all studies showed a significant 10-20% decrease in FPG from baseline and improvements in HbA1c, although the latter change often did not achieve statistical significance. These findings in patients with T2D provide the rational to test whether cinnamon exerts similar beneficial effects in patients with prediabetes.
STUDY DESIGN: This is a multi-center placebo-controlled, randomized (1:1), double masked trail to assess the effects of cinnamon (cinnamomum burmannii) on glucose homeostasis over a 12- week period. FPG, HbA1c, and other measures of glucose metabolism will be collected at baseline, after 6 weeks, and at the end of the 12-week study period. Participants will be prompted to report Adverse Events (AE) at the study visits or anytime during the study period.
OUTCOMES: The primary outcome for the Cinnamon Trial is a change in the FPG level from baseline to week 12 of treatment, as compared to placebo. Secondary outcomes include change in the FPG from baseline to week 6 of treatment, and change from baseline in plasma glucose at 2 hours and area under the curve-glucose during a 75-gram oral glucose tolerance test to week 12. Data will be analyzed using the "intent-to-treat" approach, which includes all randomized subjects with at least one post-baseline FPG measurement; the supplementation group assignment will not be altered based on the subject's adherence to the regimen.
SAMPLE SIZE DETERMINATION: Anticipating an absolute change in FPG smaller than what observed in previous studies in patients with T2D, 10 patients with prediabetes in total entering a two-treatment parallel-design study will provide 90% probability of detecting a true between-treatment difference in FPG means of 22 mg/dl with standard deviation of 10 mg/dl, using a paired two-sided comparison with type 1 error of 0.05. To allow for up to 20% dropout, 12 patients in total will be recruited.
- Conditions
- Dysglycemia, Obesity
- Being tested
- Cinnamon, placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinnamonDietary supplement
Cinnamon burmannii administered orally as 500-mg capsules three times a day over 12 weeks
placeboOther
Placebo administered orally as capsules three times a day over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon | Active comparator | Cinnamon burmannii administered orally as 500-mg capsules three times daily over 12 weeks Receives: Dietary Supplement: Cinnamon |
| Placebo | Placebo comparator | Placebo administered orally as capsules three times daily over 12 weeks Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose at 12 weeks
Change from baseline in fasting plasma glucose at 12 weeks
Measured: 12 weeks
Secondary outcomes (3)
Fasting plasma glucose at 6 weeks
Change from baseline in fasting plasma glucose at 6 weeks
Measured: 6 weeks
2-hour plasma glucose during OGTT (oral glucose tolerance test)
Change from baseline in plasma glucose obtained 2 hours during OGTT at 12 weeks
Measured: 12 weeks
Area under the curve-glucose during OGTT (oral glucose tolerance test)
Change from baseline in area under the curve of plasma glucose during OGTT at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start28 Aug 2017
- Primary completion1 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DysglycemiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kyunghee University
- Responsible party
- Sponsor
- Investigators
- Giulio R Romeo, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219411
- Sponsor's protocol ID
- CHS #:2017-15
- Acronym
- Cinnamon
- Status last verified
- Aug 2019
- First submitted
- 11 Jul 2017
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Medagama AB. The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials. Nutr J. 2015 Oct 16;14:108. doi: 10.1186/s12937-015-0098-9.
PubMed 26475130Hlebowicz J, Hlebowicz A, Lindstedt S, Bjorgell O, Hoglund P, Holst JJ, Darwiche G, Almer LO. Effects of 1 and 3 g cinnamon on gastric emptying, satiety, and postprandial blood glucose, insulin, glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and ghrelin concentrations in healthy subjects. Am J Clin Nutr. 2009 Mar;89(3):815-21. doi: 10.3945/ajcn.2008.26807. Epub 2009 Jan 21.
PubMed 19158209Khan A, Safdar M, Ali Khan MM, Khattak KN, Anderson RA. Cinnamon improves glucose and lipids of people with type 2 diabetes. Diabetes Care. 2003 Dec;26(12):3215-8. doi: 10.2337/diacare.26.12.3215.
PubMed 14633804
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-National, Double-Blind, Randomized Trial Of The Influence Of Cinnamon Powders In Subjects With Risk For Developing Diabetes
- ClinicalTrials.gov ID
- NCT03219411
- Acronym / sponsor ID
- Cinnamon / CHS #:2017-15
- Conditions
- Dysglycemia, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Kyunghee University
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 17 Jul 2017 (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 transition from normal glucose tolerance to overt type 2 diabetes mellitus (T2D) encompasses a variety of glycemic abnormalities that are commonly referred to as 'prediabetes'. While intensive lifestyle interventions are the cornerstone of T2D prevention, developing safe, cost-effective adjunct therapeutic strategies is a clinically relevant goal. Cinnamon supplementation has been shown to improve fasting plasma glucose in patients with T2D. This placebo-controlled, randomized study will determine if cinnamon improves glucose homeostasis in patients with prediabetes over a 12-week period.
Detailed description
BACKGROUND: The transition from normal glucose tolerance and insulin sensitivity to overt type 2 diabetes (T2D) encompasses a variety of glycemic abnormalities that are commonly referred to as 'prediabetes'. In 2003, 314 million people (8.2% of the adult population) had prediabetes, and this number is projected to increase to 472 million (9.0% of the adult population) by 2025. Approximately 40-50% of individuals with prediabetes have been reported to develop T2D within 10 years.
While intensive lifestyle interventions remain the cornerstone of T2D prevention, targeted pharmacotherapy has been shown to be effective and may be considered in high-risk patients. Several antidiabetic medications prevent or, at least, delay the progression from prediabetes to diabetes, including metformin, α-glucosidase inhibitors or pioglitazone. However, cost, potential adverse effects, and secondary failure in the long-term have often limited the widespread use of these and other newer antidiabetic drugs in patients with prediabetes. For instance 10 to 20% of metformin-treated patients experience gastrointestinal side effects (nausea, vomiting, and diarrhea) leading to its discontinuation, whereas the use pioglitazone is often complicated by weight gain and increased risk of fractures.
In this context, efficacious, cost-effective, and safe adjunct therapeutics for T2D prevention are highly desirable. The present trial proposes to test the effects of cinnamon in patients with prediabetes.
RATIONALE: Several randomized controlled studies have addressed the effects of cinnamon on changes in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) in adult patients with T2D. Almost all studies showed a significant 10-20% decrease in FPG from baseline and improvements in HbA1c, although the latter change often did not achieve statistical significance. These findings in patients with T2D provide the rational to test whether cinnamon exerts similar beneficial effects in patients with prediabetes.
STUDY DESIGN: This is a multi-center placebo-controlled, randomized (1:1), double masked trail to assess the effects of cinnamon (cinnamomum burmannii) on glucose homeostasis over a 12- week period. FPG, HbA1c, and other measures of glucose metabolism will be collected at baseline, after 6 weeks, and at the end of the 12-week study period. Participants will be prompted to report Adverse Events (AE) at the study visits or anytime during the study period.
OUTCOMES: The primary outcome for the Cinnamon Trial is a change in the FPG level from baseline to week 12 of treatment, as compared to placebo. Secondary outcomes include change in the FPG from baseline to week 6 of treatment, and change from baseline in plasma glucose at 2 hours and area under the curve-glucose during a 75-gram oral glucose tolerance test to week 12. Data will be analyzed using the "intent-to-treat" approach, which includes all randomized subjects with at least one post-baseline FPG measurement; the supplementation group assignment will not be altered based on the subject's adherence to the regimen.
SAMPLE SIZE DETERMINATION: Anticipating an absolute change in FPG smaller than what observed in previous studies in patients with T2D, 10 patients with prediabetes in total entering a two-treatment parallel-design study will provide 90% probability of detecting a true between-treatment difference in FPG means of 22 mg/dl with standard deviation of 10 mg/dl, using a paired two-sided comparison with type 1 error of 0.05. To allow for up to 20% dropout, 12 patients in total will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon | Active comparator | Dietary Supplement: CinnamonCinnamon burmannii administered orally as 500-mg capsules three times daily over 12 weeks |
| Placebo | Placebo comparator | Other: placeboPlacebo administered orally as capsules three times daily over 12 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 20 - 70 years old at screening
- Meet at least one of the following criteria of Prediabetes according to the 2016 American Diabetes Association criteria:
- Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
Key exclusion criteria (24 listed)
- Documented diabetes mellitus diagnosed by a physician and confirmed by other clinical data.
- Previous use of any antidiabetic medication.
- Cardiovascular disease within 6 months of the study commencement including arrhythmia, congestive heart failure, myocardial infarction or pacemaker placement.
- History of uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg on three or more assessments on more than 1 day). If the patient is on blood pressure medications, dosing should be stable for at least 4 weeks prior to randomization.
- Cancer diagnosis requiring treatment in the past 5 years
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 burmannii administered orally as 500-mg capsules three times a day over 12 weeks | Dietary supplement | Cinnamon |
| placeboPlacebo administered orally as capsules three times a day over 12 weeks | Other | Placebo |
Primary outcome
Fasting plasma glucose at 12 weeks
Time frame: 12 weeks
Change from baseline in fasting plasma glucose at 12 weeks
3 secondary outcomes
Fasting plasma glucose at 6 weeks
Time frame: 6 weeks
2-hour plasma glucose during OGTT (oral glucose tolerance test)
Time frame: 12 weeks
Area under the curve-glucose during OGTT (oral glucose tolerance test)
Time frame: 12 weeks
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 19 Aug 2019.
- Background: PubMed 26475130Medagama AB. The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials. Nutr J. 2015 Oct 16;14:108. doi: 10.1186/s12937-015-0098-9.
- Background: PubMed 19158209Hlebowicz J, Hlebowicz A, Lindstedt S, Bjorgell O, Hoglund P, Holst JJ, Darwiche G, Almer LO. Effects of 1 and 3 g cinnamon on gastric emptying, satiety, and postprandial blood glucose, insulin, glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and ghrelin concentrations in healthy subjects. Am J Clin Nutr. 2009 Mar;89(3):815-21. doi: 10.3945/ajcn.2008.26807. Epub 2009 Jan 21.
- Background: PubMed 14633804Khan A, Safdar M, Ali Khan MM, Khattak KN, Anderson RA. Cinnamon improves glucose and lipids of people with type 2 diabetes. Diabetes Care. 2003 Dec;26(12):3215-8. doi: 10.2337/diacare.26.12.3215.
- Individual participant dataSharing planned: No
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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.
Giulio R Romeo, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cinnamon in people with Dysglycemia and Obesity, run by Joslin Diabetes Center 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 6 inclusion and 24 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 19 Aug 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fasting plasma glucose at 12 weeks (time frame: 12 weeks). 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 NCT03219411, which also lists 3 linked publications.
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 19 Aug 2019.