Insulin ResistanceNCT00951639
Cassia Cinnamon for Glucose Uptake in Young Women
A study testing Cassia cinnamon, 50 minutes exercise and Cellulose Powder in people with Insulin Resistance and Impaired Glucose Tolerance, run by Baylor University at 1 site in United States.
Trial summary
The purpose of this study was to compare the acute effects of 5g of Cassia cinnamon, 50 minutes of endurance exercise performed at 70% of the heart rate reserve (correlated to VO2max), and 5g of cellulose placebo on blood glucose, serum insulin and insulin sensitivity following an oral glucose tolerance test 3 hours… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Impaired Glucose Tolerance, Prediabetes
- What is being tested?
- Cassia cinnamon, 50 minutes exercise and Cellulose Powder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2009
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary
- BMI: 27-45
- DXA body fat % greater than 30%
- 18-30 years of age
- Healthy
- From the Baylor University campus and surrounding community
- Regular sleep habits
Who cannot join
- Not regular users of any species of cinnamon
- Not diagnosed with any metabolic disorder or chronic medical condition
- Not taking prescription medications for 2 months before the study
- Not taking ergogenic aids for 2 months before the study
- Not taking oral contraceptives for 2 months before the study
- No IUD placed for 2 months before the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Department of Health, Human Performance, and Recreation
Waco, Texas, 76798
About this study
Official title: Cassia Cinnamon and Acute Endurance Exercise for the Enhancement of Glucose Uptake in Healthy Young Women
The purpose of this study was to compare the acute effects of 5g of Cassia cinnamon, 50 minutes of endurance exercise performed at 70% of the heart rate reserve (correlated to VO2max), and 5g of cellulose placebo on blood glucose, serum insulin and insulin sensitivity following an oral glucose tolerance test 3 hours after administration of each intervention.
- Conditions
- Insulin Resistance, Impaired Glucose Tolerance, Prediabetes
- Being tested
- Cassia cinnamon, 50 minutes exercise, Cellulose Powder
- Keywords
- Cassia, Cinnamon, Blood Glucose, Endurance exercise, Acute exercise, Overweight, Obesity, Women
- Medical subject headings
- Insulin Resistance, Glucose Intolerance, Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cassia cinnamonDietary supplement
Also called Brand: Nature's Bounty
5g encapsulated ground bark administered once in experimental session
50 minutes exerciseProcedure or surgery
50 minutes treadmill endurance exercise at 70% of the heart rate reserve (correlated to VO2max)
Cellulose PowderDietary supplement
5g encapsulated powder administered during placebo experimental session
| Study group | Role | What they receive |
|---|---|---|
| 5g Cassia cinnamon | Experimental | Experimental treatment group Receives: Dietary Supplement: Cassia cinnamon |
| 50 minutes endurnace exercise | Active comparator | Endurance exercise treatment known to influence blood glucose Receives: Procedure: 50 minutes exercise |
| 5g Cellulose | Placebo comparator | Placebo equivalent in weight and appearance to experimental treatment Receives: Dietary Supplement: Cellulose Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Measured: Baseline, 0, 30, 60, 90 and 120 minutes following OGTT
Secondary outcomes (1)
Serum Insulin
Measured: Baseline, 0, 30, 60, 90 and 120 minutes following OGTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darryn S Willoughby, Ph.D., Study chair, Baylor UniversityJean L Gutierrez, Ph.D., Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951639
- Sponsor's protocol ID
- BaylorU_Cassia_Women
- Status last verified
- Mar 2022
- First submitted
- 3 Aug 2009
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hlebowicz J, Darwiche G, Bjorgell O, Almer LO. Effect of cinnamon on postprandial blood glucose, gastric emptying, and satiety in healthy subjects. Am J Clin Nutr. 2007 Jun;85(6):1552-6. doi: 10.1093/ajcn/85.6.1552.
PubMed 17556692Hlebowicz 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 19158209Solomon TP, Blannin AK. Changes in glucose tolerance and insulin sensitivity following 2 weeks of daily cinnamon ingestion in healthy humans. Eur J Appl Physiol. 2009 Apr;105(6):969-76. doi: 10.1007/s00421-009-0986-9. Epub 2009 Jan 22.
PubMed 19159947Solomon TP, Blannin AK. Effects of short-term cinnamon ingestion on in vivo glucose tolerance. Diabetes Obes Metab. 2007 Nov;9(6):895-901. doi: 10.1111/j.1463-1326.2006.00694.x.
PubMed 17924872
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cassia Cinnamon and Acute Endurance Exercise for the Enhancement of Glucose Uptake in Healthy Young Women
- ClinicalTrials.gov ID
- NCT00951639
- Acronym / sponsor ID
- BaylorU_Cassia_Women
- Conditions
- Insulin Resistance, Impaired Glucose Tolerance, Prediabetes
- Keywords
- Cassia, Cinnamon, Blood Glucose, Endurance exercise, Acute exercise, Overweight, Obesity, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Aug 2009 (estimated)
- 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 purpose of this study was to compare the acute effects of 5g of Cassia cinnamon, 50 minutes of endurance exercise performed at 70% of the heart rate reserve (correlated to VO2max), and 5g of cellulose placebo on blood glucose, serum insulin and insulin sensitivity following an oral glucose tolerance test 3 hours after administration of each intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5g Cassia cinnamon | Experimental | Dietary Supplement: Cassia cinnamonExperimental treatment group |
| 50 minutes endurnace exercise | Active comparator | Procedure: 50 minutes exerciseEndurance exercise treatment known to influence blood glucose |
| 5g Cellulose | Placebo comparator | Dietary Supplement: Cellulose PowderPlacebo equivalent in weight and appearance to experimental treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sedentary
- BMI: 27-45
- DXA body fat % greater than 30%
- 18-30 years of age
- Healthy
Key exclusion criteria (6 listed)
- Not regular users of any species of cinnamon
- Not diagnosed with any metabolic disorder or chronic medical condition
- Not taking prescription medications for 2 months before the study
- Not taking ergogenic aids for 2 months before the study
- Not taking oral contraceptives for 2 months before the study
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 |
|---|---|---|
| Cassia cinnamonAlso: Brand: Nature's Bounty5g encapsulated ground bark administered once in experimental session | Dietary supplement | 5g Cassia cinnamon |
| 50 minutes exercise50 minutes treadmill endurance exercise at 70% of the heart rate reserve (correlated to VO2max) | Procedure or surgery | 50 minutes endurnace exercise |
| Cellulose Powder5g encapsulated powder administered during placebo experimental session | Dietary supplement | 5g Cellulose |
Primary outcome
Blood Glucose
Time frame: Baseline, 0, 30, 60, 90 and 120 minutes following OGTT
1 secondary outcome
Serum Insulin
Time frame: Baseline, 0, 30, 60, 90 and 120 minutes following OGTT
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 17 Mar 2022.
- Background: PubMed 17556692Hlebowicz J, Darwiche G, Bjorgell O, Almer LO. Effect of cinnamon on postprandial blood glucose, gastric emptying, and satiety in healthy subjects. Am J Clin Nutr. 2007 Jun;85(6):1552-6. doi: 10.1093/ajcn/85.6.1552.
- 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 19159947Solomon TP, Blannin AK. Changes in glucose tolerance and insulin sensitivity following 2 weeks of daily cinnamon ingestion in healthy humans. Eur J Appl Physiol. 2009 Apr;105(6):969-76. doi: 10.1007/s00421-009-0986-9. Epub 2009 Jan 22.
- Background: PubMed 17924872Solomon TP, Blannin AK. Effects of short-term cinnamon ingestion on in vivo glucose tolerance. Diabetes Obes Metab. 2007 Nov;9(6):895-901. doi: 10.1111/j.1463-1326.2006.00694.x.
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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.
Darryn S Willoughby, Ph.D. study chair
Baylor University
Jean L Gutierrez, Ph.D. principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cassia cinnamon, 50 minutes exercise and Cellulose Powder in people with Insulin Resistance and Impaired Glucose Tolerance, run by Baylor University 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 7 inclusion and 6 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 17 Mar 2022. 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 (time frame: Baseline, 0, 30, 60, 90 and 120 minutes following OGTT). 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 NCT00951639, which also lists 4 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 17 Mar 2022.