Metabolic SyndromeNCT02455778
Effect of Oral Cinnamon Intervention in Metabolic Syndrome
A study testing Cinnamon in people with Metabolic Syndrome, run by Diabetes Foundation, India at 1 site in India.
Trial summary
This double blind placebo control study with supplementation of oral Cinnamon is being conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may lead to improvement in body composition and metabolic parameters. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- 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
- 103 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2011to Apr 2013
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged between 25 -65 years
- Subjects identified with any three of following:
- Fasting blood glucose ≥100 mg/ dL
- Waist circumference ≥ 90 cm ( males) ≥ 80 cm (females)
- Triglycerides ≥ 150 mg/dL
- High density lipoprotein cholesterol ≤ 40 mg/dL ( in males) , ≤ 50 mg/dL (in females)
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- Blood pressure Systolic BP ≥ 130 mm Hg
- Diastolic BP ≥ 85 mm Hg
- Subjects who were willing to participate in the study.
- Subjects, if on medication for high blood pressure were stable and there was no change in the dosage for the past 3 months.
Who cannot join
- Subjects suffering from other chronic diseases and metabolic complications such as cardiovascular disease, diabetes, renal disease, myocardial infarction and other endocrine disorders.
- Subjects who were allergic to wheat flour and cinnamon.
- Subjects who were on medication of anti dyslipidemic or hypoglycemic drugs.
- Subjects who had undergone bypass procedure.
- Subjects suffering from any debilitating disease such as tuberculosis, HIV etc.
- Subjects suffering from uncontrolled hypothyroidism/ hyperthyroidism
- Pregnant and lactating mothers
Trial locations and contacts
1 site in 1 country.
India1 site
Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology
Delhi
About this study
Official title: Effect of Intervention With Oral Cinnamon on Metabolic Profile and Body Composition of Asian Indians With Metabolic Syndrome in North India: A 16 Week Double Blind Placebo Control Trial
This double blind placebo control study with supplementation of oral Cinnamon is being conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may lead to improvement in body composition and metabolic parameters.
- Conditions
- Metabolic Syndrome
- Being tested
- Cinnamon, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinnamonDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon | Experimental | 3 grams of oral cinnamon per day in form of capsules (6) along with standard diet and exercise protocol Receives: Dietary Supplement: Cinnamon |
| Placebo | Placebo comparator | 2.5 grams of wheat flour per day in form of capsules ( 6) along with standard diet and exercise protocol Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
Measured: baseline to 4 months
Secondary outcomes (4)
HbA1c
Measured: baseline to 4 months
Lipid profile
Measured: baseline to 4 months
Body fat percentage
Measured: baseline to 4 months
Blood pressure
Measured: baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionApr 2013
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 Metabolic SyndromeStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Home Economics, India
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455778
- Sponsor's protocol ID
- Cinnamon 2010
- Status last verified
- May 2015
- First submitted
- 25 May 2015
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gupta Jain S, Puri S, Misra A, Gulati S, Mani K. Effect of oral cinnamon intervention on metabolic profile and body composition of Asian Indians with metabolic syndrome: a randomized double -blind control trial. Lipids Health Dis. 2017 Jun 12;16(1):113. doi: 10.1186/s12944-017-0504-8.
PubMed 28606084
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intervention With Oral Cinnamon on Metabolic Profile and Body Composition of Asian Indians With Metabolic Syndrome in North India: A 16 Week Double Blind Placebo Control Trial
- ClinicalTrials.gov ID
- NCT02455778
- Acronym / sponsor ID
- Cinnamon 2010
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- Institute of Home Economics, India
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 May 2015 (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.
This double blind placebo control study with supplementation of oral Cinnamon is being conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may lead to improvement in body composition and metabolic parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon | Experimental | Dietary Supplement: Cinnamon3 grams of oral cinnamon per day in form of capsules (6) along with standard diet and exercise protocol |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2.5 grams of wheat flour per day in form of capsules ( 6) along with standard diet and exercise protocol |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects aged between 25 -65 years
- Subjects identified with any three of following:
- Subjects who were willing to participate in the study.
- Subjects, if on medication for high blood pressure were stable and there was no change in the dosage for the past 3 months.
Key exclusion criteria (7 listed)
- Subjects suffering from other chronic diseases and metabolic complications such as cardiovascular disease, diabetes, renal disease, myocardial infarction and other endocrine disorders.
- Subjects who were allergic to wheat flour and cinnamon.
- Subjects who were on medication of anti dyslipidemic or hypoglycemic drugs.
- Subjects who had undergone bypass procedure.
- Subjects suffering from any debilitating disease such as tuberculosis, HIV etc.
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 | Dietary supplement | Cinnamon |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Fasting Blood Glucose
Time frame: baseline to 4 months
4 secondary outcomes
HbA1c
Time frame: baseline to 4 months
Lipid profile
Time frame: baseline to 4 months
Body fat percentage
Time frame: baseline to 4 months
Blood pressure
Time frame: baseline to 4 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 29 May 2015.
- Derived from this study: PubMed 28606084Gupta Jain S, Puri S, Misra A, Gulati S, Mani K. Effect of oral cinnamon intervention on metabolic profile and body composition of Asian Indians with metabolic syndrome: a randomized double -blind control trial. Lipids Health Dis. 2017 Jun 12;16(1):113. doi: 10.1186/s12944-017-0504-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metabolic Syndrome, run by Diabetes Foundation, India at 1 site in India.
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 10 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 29 May 2015. 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 India. 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?
Fasting Blood Glucose (time frame: baseline to 4 months). 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 NCT02455778, 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 29 May 2015.