An interventional study of Berberine and Placebo in Cardiometabolic Syndrome, sponsored by University of Central Lancashire. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by University of Central Lancashire · Not applicable, Interventional, and Prevention
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Central Lancashire is the lead sponsor of 31 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Berberine
Other: Placebo
Berberine supplement 500 mg 2 x per day
Placebo control 2 x blinded placebo tablet per day
Blood triglycerides
Capillary blood triglycerides - mmol/L
Time frame: Baseline
Blood triglycerides
Capillary blood triglycerides - mmol/L
Time frame: 20-days
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Time frame: Baseline
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Time frame: 20-days
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Time frame: Baseline
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Time frame: 20-days
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Time frame: Baseline
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Time frame: 20-days
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Time frame: Baseline
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Time frame: 20-days
Blood glucose
Capillary blood glucose - mmol/L
Time frame: Baseline
Blood glucose
Capillary blood glucose - mmol/L
Time frame: 20-days
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Time frame: Baseline
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Time frame: 20-days
Blood cholesterol - Total
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Blood cholesterol - Total
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Blood cholesterol - LDL
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Blood cholesterol - LDL
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Blood cholesterol - HDL
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Blood cholesterol - HDL
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Time frame: Baseline
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20-days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Aug 2028, 25 months later.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 25 months is above that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Berberine
University of Central Lancashire