DiabetesNCT05570357
Berberine and Cinnamon in Management of Diabetes
A study testing Berberine+Cinnamon (TDS) in people with Diabetes, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
In this randomized clinical trial, patients with diabetes will be randomly assigned to receive either Berberine, and Cinnamon supplements or placebo for 12 weeks. Then the glycemic characteristics will be compared in two groups. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Berberine+Cinnamon (TDS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2022to 10 Feb 2023
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-70 years
- Diagnosed type-2 diabetes mellitus (based on American Diabetes Association criteria)
Who cannot join
- Patients with an allergy to berberine /cinamon
- Lactation, pregnancy
- Patients with any malignancy
- Patients with unrelated chronic illness
- Patients with cardiac, liver or respiratory failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Berberine and Cinnamon Supplementation on Diabetes Mangement
In this randomized clinical trial, patients with diabetes will be randomly assigned to receive either Berberine, and Cinnamon supplements or placebo for 12 weeks. Then the glycemic characteristics will be compared in two groups.
- Conditions
- Diabetes
- Being tested
- Berberine+Cinnamon (TDS), Placebo (TDS)
- Keywords
- Diabetes, Berberine, Cinnamon
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine+Cinnamon (TDS)Dietary supplement
The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract
Placebo (TDS)Other
Placebo contains Maltodexterin
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Dietary Supplement: Berberine+Cinnamon (TDS) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo (TDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
HbA1C change from baseline
Measured: 0 and 12th week
Secondary outcomes (5)
Fasting blood sugar
Blood sugar change from baseline
Measured: 0 and 12th week
Lipid profile
lipid profiles change from baseline
Measured: 0 and 12th week
Anthropometric measurements
weight, height, BMI, WC
Measured: 0 and 12th week
Blood Pressure
measuring according to the BP measurement guideline
Measured: 0 and 12th week
CRP
measuring the blood concentration of C-reactive protein
Measured: 0 and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Jul 2022
- Primary completion1 Jan 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570357
- Sponsor's protocol ID
- 996401
- Status last verified
- Jun 2024
- First submitted
- 2 Oct 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Berberine and Cinnamon Supplementation on Diabetes Mangement
- ClinicalTrials.gov ID
- NCT05570357
- Acronym / sponsor ID
- 996401
- Conditions
- Diabetes
- Keywords
- Diabetes, Berberine, Cinnamon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 6 Oct 2022 (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.
In this randomized clinical trial, patients with diabetes will be randomly assigned to receive either Berberine, and Cinnamon supplements or placebo for 12 weeks. Then the glycemic characteristics will be compared in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Berberine+Cinnamon (TDS) |
| Placebo | Placebo comparator | Other: Placebo (TDS) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 30-70 years
- Diagnosed type-2 diabetes mellitus (based on American Diabetes Association criteria)
Key exclusion criteria (5 listed)
- Patients with an allergy to berberine /cinamon
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 |
|---|---|---|
| Berberine+Cinnamon (TDS)The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract | Dietary supplement | Intervention |
| Placebo (TDS)Placebo contains Maltodexterin | Other | Placebo |
Primary outcome
HbA1C
Time frame: 0 and 12th week
HbA1C change from baseline
5 secondary outcomes
Fasting blood sugar
Time frame: 0 and 12th week
Lipid profile
Time frame: 0 and 12th week
Anthropometric measurements
Time frame: 0 and 12th week
Blood Pressure
Time frame: 0 and 12th week
CRP
Time frame: 0 and 12th week
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 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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 Berberine+Cinnamon (TDS) in people with Diabetes, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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 2 inclusion and 5 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 11 Jun 2024. 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 Iran. 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?
HbA1C (time frame: 0 and 12th week). 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 11 Jun 2024.