Type 2 Diabetes MellitusPhase 2cinnamonNCT00846898
Is There a Metabolic Effect of Cinnamon on HbA1c, Blood Pressure and Serum Lipids in Type 2 Diabetes Mellitus?
A Phase 2 study testing cinnamon 2g per day for 12 weeks in people with Type 2 Diabetes Mellitus, run by Thames Valley University at 1 site in United Kingdom.
Trial summary
The aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- cinnamon 2g per day for 12 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2008to Feb 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type 2 diabetes mellitus
- Aged over 18 years, either sex
- HbA1c level more than 7%
- Patients treated only with oral anti-diabetic drugs or diet
Who cannot join
- Patients with severe health problems including renal disease, liver disease, cardiovascular disease and other chronic ill health conditions
- Patients with mental health problems
- Patients treated with insulin therapy
- Patients refused to give informed consent
- Pregnant and lactating women
- Patients taking cinnamon supplements and other herbal supplements known to be effective
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brent teaching Primary Care trust (NHS)
Wembley, London, HA0 4UZ
About this study
Official title: The Effect of Dietary Supplementation of Cinnamon (Cinnamon Cassia) on HbA1c, Blood Pressure and Serum Lipid Measurements in Patients With Type 2 Diabetes Mellitus: a Randomised Placebo Controlled, Double Blind Clinical Trial
The aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in patients with type 2 diabetes mellitus.
Read the detailed description
The study will be conducted for 3 months (12 weeks) with 58 individuals diagnosed with type 2 diabetes mellitus. The randomisation will be carried out by using a randomisation list. Cinnamon bark (cinnamon cassia) and starch flour (placebo) capsules will be purchased from a local pharmaceutical company in UK; these are freely available for over the counter use. Each capsule contained either 500 mg of cinnamon powder or starch flour. The cinnamon and placebo (starch flour) capsules will be packaged in a non transparent plastic bags.
The patients will be randomly allocated into the two groups of:
Group 1: placebo control group Group 2: cinnamon group
Patients in both placebo and cinnamon groups will receive treatment similar to the treatment they would normally receive from their respective NHS or primary care trust for 12 weeks.
Data collection:
After the randomisation the subjects will be scheduled to visit the clinic at 0 weeks, 6 - 7 weeks and 12 weeks from the beginning of the study. During every visit (week 0, weeks 6 - 7 and week 12) a 3-day diet diary will be collected and the intake of total calories, fats, carbohydrates, proteins and fibre will be determined. Compliance with the diet will be monitored by individual discussions at each clinical visit with dietician and compared with the diet diary. The anthropometric measurements of body weight, height, waist and hip circumferences will be measured before the trial (week 0), during the trial (weeks 6 - 7) and after the trial (week 12) period. The recorded clinical measurements of blood profiles include HbA1c level, fasting plasma glucose concentration and serum lipid profiles including serum total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and serum triglycerides, systolic and diastolic blood pressures will be measured at the baseline (week 0) and at 12 weeks during the study period.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- cinnamon 2g per day for 12 weeks
- Keywords
- blood sugar, cholesterol, cinnamon, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinnamon 2g per day for 12 weeksDietary supplement
Also called cinnamon
Subjects in intervention group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
| Study group | Role | What they receive |
|---|---|---|
| cinnamon | Experimental | Subjects in this group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals. Receives: Dietary Supplement: cinnamon 2g per day for 12 weeks |
| Control | Placebo comparator | Subjects in this group will receive placebo capsules (starch flour) for 12 weeks period. The 2 g dose of starch capsules will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals. Receives: Dietary Supplement: cinnamon 2g per day for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 3 months
Secondary outcomes (1)
Plasma glucose concentration Plasma lipid profiles (HDL, LDL, Triglycerides and total cholesterol) systolic and diastolic blood pressures. Body Mass Index. Waist circumference. Total calorie intake.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thames Valley University
- Sponsor type
- University, hospital or other
- Collaborators
- Wembley Health Care centre, NHS, UK., Monks Park Primary care centre, NHS UK., Willesden Health centre, NHS, UK.
- Investigators
- Amalia Tsiami, PhD,MSc,BSc, Study director, Thames Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846898
- Sponsor's protocol ID
- 07/H0717/47
- Acronym
- cinnamon
- Status last verified
- Feb 2009
- First submitted
- 18 Feb 2009
- Last updated
- 14 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Supplementation of Cinnamon (Cinnamon Cassia) on HbA1c, Blood Pressure and Serum Lipid Measurements in Patients With Type 2 Diabetes Mellitus: a Randomised Placebo Controlled, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT00846898
- Acronym / sponsor ID
- cinnamon / 07/H0717/47
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- blood sugar, cholesterol, cinnamon, HbA1c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Thames Valley UniversityUniversity, hospital or other
- Collaborators
- Wembley Health Care centre, NHS, UK., Monks Park Primary care centre, NHS UK., Willesden Health centre, NHS, UK.
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Feb 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 aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in patients with type 2 diabetes mellitus.
Detailed description
The study will be conducted for 3 months (12 weeks) with 58 individuals diagnosed with type 2 diabetes mellitus. The randomisation will be carried out by using a randomisation list. Cinnamon bark (cinnamon cassia) and starch flour (placebo) capsules will be purchased from a local pharmaceutical company in UK; these are freely available for over the counter use. Each capsule contained either 500 mg of cinnamon powder or starch flour. The cinnamon and placebo (starch flour) capsules will be packaged in a non transparent plastic bags.
The patients will be randomly allocated into the two groups of:
Group 1: placebo control group Group 2: cinnamon group
Patients in both placebo and cinnamon groups will receive treatment similar to the treatment they would normally receive from their respective NHS or primary care trust for 12 weeks.
Data collection:
After the randomisation the subjects will be scheduled to visit the clinic at 0 weeks, 6 - 7 weeks and 12 weeks from the beginning of the study. During every visit (week 0, weeks 6 - 7 and week 12) a 3-day diet diary will be collected and the intake of total calories, fats, carbohydrates, proteins and fibre will be determined. Compliance with the diet will be monitored by individual discussions at each clinical visit with dietician and compared with the diet diary. The anthropometric measurements of body weight, height, waist and hip circumferences will be measured before the trial (week 0), during the trial (weeks 6 - 7) and after the trial (week 12) period. The recorded clinical measurements of blood profiles include HbA1c level, fasting plasma glucose concentration and serum lipid profiles including serum total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and serum triglycerides, systolic and diastolic blood pressures will be measured at the baseline (week 0) and at 12 weeks during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cinnamon | Experimental | Dietary Supplement: cinnamon 2g per day for 12 weeksSubjects in this group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals. |
| Control | Placebo comparator | Dietary Supplement: cinnamon 2g per day for 12 weeksSubjects in this group will receive placebo capsules (starch flour) for 12 weeks period. The 2 g dose of starch capsules will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with type 2 diabetes mellitus
- Aged over 18 years, either sex
- HbA1c level more than 7%
- Patients treated only with oral anti-diabetic drugs or diet
Key exclusion criteria (6 listed)
- Patients with severe health problems including renal disease, liver disease, cardiovascular disease and other chronic ill health conditions
- Patients with mental health problems
- Patients treated with insulin therapy
- Patients refused to give informed consent
- Pregnant and lactating women
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 |
|---|---|---|
| cinnamon 2g per day for 12 weeksAlso: cinnamonSubjects in intervention group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals. | Dietary supplement | Control, cinnamon |
Primary outcome
HbA1c
Time frame: 3 months
1 secondary outcome
Plasma glucose concentration Plasma lipid profiles (HDL, LDL, Triglycerides and total cholesterol) systolic and diastolic blood pressures. Body Mass Index. Waist circumference. Total calorie intake.
Time frame: 3 months
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 14 Nov 2011.
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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.
Amalia Tsiami, PhD,MSc,BSc study director
Thames Valley University
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 2g per day for 12 weeks in people with Type 2 Diabetes Mellitus, run by Thames Valley University at 1 site in United Kingdom.
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 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 14 Nov 2011. 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 Kingdom. 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?
HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2011.