Cardiometabolic SyndromeNCT07541898
Effects of Berberine on Cardiometabolic Outcomes
A study testing Berberine in people with Cardiometabolic Syndrome, run by University of Central Lancashire.
Trial summary
Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Syndrome
- What is being tested?
- Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Between 18 \& 65 years
- Non-smoker
- BMI < 30
- Able to give informed consent
Who cannot join
- Pregnancy
- Diabetes or any other metabolic/ uncontrolled hypertensive conditions
- Food allergies to berberine
- Habitual consumption of berberine
- Not regularly taking medication or antioxidant supplements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Berberine Supplementation on Cardiometabolic Parameters
Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Berberine may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.
- Conditions
- Cardiometabolic Syndrome
- Being tested
- Berberine, 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.
BerberineDietary supplement
Berberine supplement 500 mg 2 x per day
PlaceboOther
Placebo control 2 x blinded placebo tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Berberine tablets 500mg 2 x p/d | Experimental | Not described Receives: Dietary Supplement: Berberine |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: Baseline
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: 20-days
Secondary outcomes (30)
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Measured: Baseline
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Measured: 20-days
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Measured: Baseline
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Measured: 20-days
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Measured: Baseline
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Measured: 20-days
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: Baseline
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: 20-days
Blood glucose
Capillary blood glucose - mmol/L
Measured: Baseline
Blood glucose
Capillary blood glucose - mmol/L
Measured: 20-days
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Measured: Baseline
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Measured: 20-days
Blood cholesterol - Total
Capillary blood cholesterol - mmol/L
Measured: Baseline
Blood cholesterol - Total
Capillary blood cholesterol - mmol/L
Measured: 20-days
Blood cholesterol - LDL
Capillary blood cholesterol - mmol/L
Measured: Baseline
Blood cholesterol - LDL
Capillary blood cholesterol - mmol/L
Measured: 20-days
Blood cholesterol - HDL
Capillary blood cholesterol - mmol/L
Measured: Baseline
Blood cholesterol - HDL
Capillary blood cholesterol - mmol/L
Measured: 20-days
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Measured: Baseline
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Measured: 20-days
Beck Depression Inventory
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Measured: Baseline
Beck Depression Inventory
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Measured: 20-days
State Trait Anxiety Inventory
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Measured: Baseline
State Trait Anxiety Inventory
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Measured: 20-days
Insomnia Severity Index
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Measured: Baseline
Insomnia Severity Index
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Measured: 20-days
Pittsburgh Sleep Quality Index
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Measured: Baseline
Pittsburgh Sleep Quality Index
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Measured: 20-days
Epworth Sleepiness Scale
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Measured: Baseline
Epworth Sleepiness Scale
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Measured: 20-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- DoNotAge.org
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541898
- Sponsor's protocol ID
- Berberine cardiometabolic
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Berberine Supplementation on Cardiometabolic Parameters
- ClinicalTrials.gov ID
- NCT07541898
- Acronym / sponsor ID
- Berberine cardiometabolic
- Conditions
- Cardiometabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- DoNotAge.org
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 21 Apr 2026 (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.
Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Berberine may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine tablets 500mg 2 x p/d | Experimental | Dietary Supplement: Berberine |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- Between 18 \& 65 years
- Non-smoker
- BMI < 30
- Able to give informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Diabetes or any other metabolic/ uncontrolled hypertensive conditions
- Food allergies to berberine
- Habitual consumption of berberine
- Not regularly taking medication or antioxidant supplements
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 |
|---|---|---|
| BerberineBerberine supplement 500 mg 2 x per day | Dietary supplement | Berberine tablets 500mg 2 x p/d |
| PlaceboPlacebo control 2 x blinded placebo tablet per day | Other | Placebo |
Primary outcome
Blood triglycerides
Time frame: Baseline
Capillary blood triglycerides - mmol/L
Blood triglycerides
Time frame: 20-days
Capillary blood triglycerides - mmol/L
30 secondary outcomes
Systolic blood pressure
Time frame: Baseline
Systolic blood pressure
Time frame: 20-days
Diastolic blood pressure
Time frame: Baseline
Diastolic blood pressure
Time frame: 20-days
Percent bodyfat
Time frame: Baseline
Percent bodyfat
Time frame: 20-days
Waist to hip ratio
Time frame: Baseline
Waist to hip ratio
Time frame: 20-days
Blood glucose
Time frame: Baseline
Blood glucose
Time frame: 20-days
Triglyceride glucose index
Time frame: Baseline
Triglyceride glucose index
Time frame: 20-days
Blood cholesterol - Total
Time frame: Baseline
Blood cholesterol - Total
Time frame: 20-days
Blood cholesterol - LDL
Time frame: Baseline
Blood cholesterol - LDL
Time frame: 20-days
Blood cholesterol - HDL
Time frame: Baseline
Blood cholesterol - HDL
Time frame: 20-days
Coop-Wonka chart
Time frame: Baseline
Coop-Wonka chart
Time frame: 20-days
Beck Depression Inventory
Time frame: Baseline
Beck Depression Inventory
Time frame: 20-days
State Trait Anxiety Inventory
Time frame: Baseline
State Trait Anxiety Inventory
Time frame: 20-days
Insomnia Severity Index
Time frame: Baseline
Insomnia Severity Index
Time frame: 20-days
Pittsburgh Sleep Quality Index
Time frame: Baseline
Pittsburgh Sleep Quality Index
Time frame: 20-days
Epworth Sleepiness Scale
Time frame: Baseline
Epworth Sleepiness Scale
Time frame: 20-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine in people with Cardiometabolic Syndrome, run by University of Central Lancashire.
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 5 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: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan K Sinclair, PhD, DSc (01772892796, jksinclair@lancashire.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood triglycerides (time frame: Baseline). The study lists 2 primary outcomes in all. 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 21 Apr 2026.