Postprandial GlycemiaNCT02074423
A Human Clinical Trial Evaluating the Effect of MealShape™ on Blood Glucose Level Following Consumption of Standard Meal
A study testing MealShape cinnamon extract in people with Postprandial Glycemia and Postprandial Insulinemia, run by Dialpha at 1 site in France.
Trial summary
The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard meal composed of white bread, in healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glycemia, Postprandial Insulinemia
- What is being tested?
- MealShape cinnamon extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Feb 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers, able to read and write, aged from 18 to 45 years inclusive at time of screening
- Good physical condition
- Body Mass Index (BMI) ≥ 18,5 and < 25 kg/m²
- Written informed consent provided prior to screening, after receiving and understanding the subject information
- Stable body weight (< 5% variation) within the last 3 months prior to screening.
- Subject accepting to keep the same lifestyle throughout the study regarding physical activity, no smoking etc.
- Registered with the French Social Security, in agreement with the French law on biomedical experimentation.
Who cannot join
- Subject with type 1 or 2 diabetes
- Smoker. Light smoker (less than 5 cigarettes per day) or former smoker (smoking more than 5 cigarettes per day) having stopped less than three months. Smoking (or use of smoking substitute e.g. nicotine patch) is not permitted from screening throughout the study.
- Subject with fasting capillary blood glucose level > 110 mg/dl.
- Subject with fasting capillary blood glucose level ≤ 110 mg/dl and 2 hours postprandial capillary blood glucose level > 140 mg/dl during an Oral Glucose Tolerance Test.
- Subject with any sensitivity or allergy to any of the products used within this clinical trial.
- Intake of product (food and dietary supplement) having an effect on glycemia and insulinemia.
- Intake of all chronic medication excepted oestroprogestative or progestative contraception started at least three months preceding the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Double-blind, Cross-over Clinical Trial, Evaluating the Effect of MealShape™ on the Postprandial Glycemia After Eating Standard Food, in Healthy Volunteers.
The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard meal composed of white bread, in healthy male and female volunteers.
- Conditions
- Postprandial Glycemia, Postprandial Insulinemia
- Being tested
- MealShape cinnamon extract, Placebo
- Keywords
- Cinnamon extract, Postprandial glycemia, Glycemic index, Pre-diabetes, Metabolic syndrome
- Medical subject headings
- Glucose Intolerance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealShape cinnamon extractDietary supplement
Acute administration of 1 g PO (2 capsules of 500 mg)
PlaceboDietary supplement
Acute administration of 1 g PO (2 capsules of 500 mg)
| Study group | Role | What they receive |
|---|---|---|
| MealShape cinnamon extract | Experimental | Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread) Receives: Dietary Supplement: MealShape cinnamon extract |
| Placebo | Placebo comparator | Intake of 2 capsules of 500 mg placebo, composed of 20% microcrystalline cellulose and 80% dicalcium phosphate, 30 minutes before consumption of a standard meal (white bread) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose incremental Area Under the Curve between 0 and 120 minutes after consumption of a standard meal, compared between MealShape and the placebo
Measured: Over 120 minutes after the consumption of a standard meal
Secondary outcomes (6)
Blood glucose incremental Area Under the Curve between 0 and 60 minutes compared between MealShape and the placebo after consumption of a standard meal,
Measured: Over 60 minutes after consumption of a standard meal
Capillary blood glucose maximal concentration between MealShape and Placebo after consumption of a standard meal
Measured: Over 120 minutes after consumption of a standard meal
Comparison of glycemia values between MealShape and Placebo at the following time points: T0, T15, T30, T45, T60, T90 and T120 minutes after consumption of a standard meal
Measured: Over 120 minutes after consumption of a standard meal
Evaluation of the safety of MealShape with adverse events recording
Measured: 3 weeks
Insulin incremental Area under the Curve between 0 and 120 minutes compared between MealShape and Placebo after consumption of a standard meal
Measured: Over 120 minutes after consumption of a standard meal
Insulin incremental Area under the Curve between 0 and 60 minutes compared between MealShape and Placebo after consumption of a standard meal
Measured: Over 60 minutes after connsumption of a standard meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postprandial GlycemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dialpha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Deplanque, Principal investigator, Naturalpha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074423
- Sponsor's protocol ID
- 12-026
- Status last verified
- Feb 2014
- First submitted
- 26 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.
PubMed 11742409Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026.
PubMed 22608371Rafehi H, Ververis K, Karagiannis TC. Controversies surrounding the clinical potential of cinnamon for the management of diabetes. Diabetes Obes Metab. 2012 Jun;14(6):493-9. doi: 10.1111/j.1463-1326.2011.01538.x. Epub 2011 Dec 27.
PubMed 22093965Davis PA, Yokoyama W. Cinnamon intake lowers fasting blood glucose: meta-analysis. J Med Food. 2011 Sep;14(9):884-9. doi: 10.1089/jmf.2010.0180. Epub 2011 Apr 11.
PubMed 21480806Baker WL, Gutierrez-Williams G, White CM, Kluger J, Coleman CI. Effect of cinnamon on glucose control and lipid parameters. Diabetes Care. 2008 Jan;31(1):41-3. doi: 10.2337/dc07-1711. Epub 2007 Oct 1.
PubMed 17909085Magistrelli A, Chezem JC. Effect of ground cinnamon on postprandial blood glucose concentration in normal-weight and obese adults. J Acad Nutr Diet. 2012 Nov;112(11):1806-9. doi: 10.1016/j.jand.2012.07.037.
PubMed 23102179Beejmohun V, Peytavy-Izard M, Mignon C, Muscente-Paque D, Deplanque X, Ripoll C, Chapal N. Acute effect of Ceylon cinnamon extract on postprandial glycemia: alpha-amylase inhibition, starch tolerance test in rats, and randomized crossover clinical trial in healthy volunteers. BMC Complement Altern Med. 2014 Sep 23;14:351. doi: 10.1186/1472-6882-14-351.
PubMed 25249234
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind, Cross-over Clinical Trial, Evaluating the Effect of MealShape™ on the Postprandial Glycemia After Eating Standard Food, in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02074423
- Acronym / sponsor ID
- 12-026
- Conditions
- Postprandial Glycemia, Postprandial Insulinemia
- Keywords
- Cinnamon extract, Postprandial glycemia, Glycemic index, Pre-diabetes, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- DialphaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Feb 2014 (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 the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard meal composed of white bread, in healthy male and female volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MealShape cinnamon extract | Experimental | Dietary Supplement: MealShape cinnamon extractIntake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIntake of 2 capsules of 500 mg placebo, composed of 20% microcrystalline cellulose and 80% dicalcium phosphate, 30 minutes before consumption of a standard meal (white bread) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male and female volunteers, able to read and write, aged from 18 to 45 years inclusive at time of screening
- Good physical condition
- Body Mass Index (BMI) ≥ 18,5 and < 25 kg/m²
- Written informed consent provided prior to screening, after receiving and understanding the subject information
- Stable body weight (< 5% variation) within the last 3 months prior to screening.
Key exclusion criteria (7 listed)
- Subject with type 1 or 2 diabetes
- Smoker. Light smoker (less than 5 cigarettes per day) or former smoker (smoking more than 5 cigarettes per day) having stopped less than three months. Smoking (or use of smoking substitute e.g. nicotine patch) is not permitted from screening throughout the study.
- Subject with fasting capillary blood glucose level > 110 mg/dl.
- Subject with fasting capillary blood glucose level ≤ 110 mg/dl and 2 hours postprandial capillary blood glucose level > 140 mg/dl during an Oral Glucose Tolerance Test.
- Subject with any sensitivity or allergy to any of the products used within this clinical trial.
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 |
|---|---|---|
| MealShape cinnamon extractAcute administration of 1 g PO (2 capsules of 500 mg) | Dietary supplement | MealShape cinnamon extract |
| PlaceboAcute administration of 1 g PO (2 capsules of 500 mg) | Dietary supplement | Placebo |
Primary outcome
Blood glucose incremental Area Under the Curve between 0 and 120 minutes after consumption of a standard meal, compared between MealShape and the placebo
Time frame: Over 120 minutes after the consumption of a standard meal
6 secondary outcomes
Blood glucose incremental Area Under the Curve between 0 and 60 minutes compared between MealShape and the placebo after consumption of a standard meal,
Time frame: Over 60 minutes after consumption of a standard meal
Capillary blood glucose maximal concentration between MealShape and Placebo after consumption of a standard meal
Time frame: Over 120 minutes after consumption of a standard meal
Comparison of glycemia values between MealShape and Placebo at the following time points: T0, T15, T30, T45, T60, T90 and T120 minutes after consumption of a standard meal
Time frame: Over 120 minutes after consumption of a standard meal
Evaluation of the safety of MealShape with adverse events recording
Time frame: 3 weeks
Insulin incremental Area under the Curve between 0 and 120 minutes compared between MealShape and Placebo after consumption of a standard meal
Time frame: Over 120 minutes after consumption of a standard meal
Insulin incremental Area under the Curve between 0 and 60 minutes compared between MealShape and Placebo after consumption of a standard meal
Time frame: Over 60 minutes after connsumption of a standard meal
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 Feb 2014.
- Background: PubMed 11742409Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.
- Background: PubMed 22608371Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026.
- Background: PubMed 22093965Rafehi H, Ververis K, Karagiannis TC. Controversies surrounding the clinical potential of cinnamon for the management of diabetes. Diabetes Obes Metab. 2012 Jun;14(6):493-9. doi: 10.1111/j.1463-1326.2011.01538.x. Epub 2011 Dec 27.
- Background: PubMed 21480806Davis PA, Yokoyama W. Cinnamon intake lowers fasting blood glucose: meta-analysis. J Med Food. 2011 Sep;14(9):884-9. doi: 10.1089/jmf.2010.0180. Epub 2011 Apr 11.
- Background: PubMed 17909085Baker WL, Gutierrez-Williams G, White CM, Kluger J, Coleman CI. Effect of cinnamon on glucose control and lipid parameters. Diabetes Care. 2008 Jan;31(1):41-3. doi: 10.2337/dc07-1711. Epub 2007 Oct 1.
- Background: PubMed 23102179Magistrelli A, Chezem JC. Effect of ground cinnamon on postprandial blood glucose concentration in normal-weight and obese adults. J Acad Nutr Diet. 2012 Nov;112(11):1806-9. doi: 10.1016/j.jand.2012.07.037.
- Derived from this study: PubMed 25249234Beejmohun V, Peytavy-Izard M, Mignon C, Muscente-Paque D, Deplanque X, Ripoll C, Chapal N. Acute effect of Ceylon cinnamon extract on postprandial glycemia: alpha-amylase inhibition, starch tolerance test in rats, and randomized crossover clinical trial in healthy volunteers. BMC Complement Altern Med. 2014 Sep 23;14:351. doi: 10.1186/1472-6882-14-351.
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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.
Xavier Deplanque principal investigator
Naturalpha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MealShape cinnamon extract in people with Postprandial Glycemia and Postprandial Insulinemia, run by Dialpha at 1 site in France.
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 7 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 Feb 2014. 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 France. 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 incremental Area Under the Curve between 0 and 120 minutes after consumption of a standard meal, compared between MealShape and the placebo (time frame: Over 120 minutes after the consumption of a standard meal). 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 NCT02074423, which also lists 7 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 28 Feb 2014.