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Effects of Berberine on Cardiometabolic Outcomes

NCT07541898 — Not applicable, Not yet recruiting, 40 participants, University of Central Lancashire

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Effects of Berberine Supplementation on Cardiometabolic Parameters

RegistryNCT07541898
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment40 (Estimated)
SponsorUniversity of Central Lancashire (Other); collaborators: DoNotAge.org
ConditionsCardiometabolic Syndrome
InterventionsBerberine, Placebo (Dietary supplement, other)
Datesstart 2026-07-01 (estimated), primary completion 2028-08-01 (estimated), completion 2029-01-01 (estimated), first posted 2026-04-21, last updated 2026-04-21

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-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. 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.

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+Arms and interventions

ArmTypeInterventionsDescription
Berberine tablets 500mg 2 x p/dExperimentalDietary Supplement: Berberine
PlaceboPlacebo comparatorOther: Placebo
  • Berberine (Dietary supplement): Berberine supplement 500 mg 2 x per day
  • Placebo (Other): Placebo control 2 x blinded placebo tablet per day

+Outcome measures

Primary outcomes

  • Blood triglycerides [Baseline]: Capillary blood triglycerides - mmol/L
  • Blood triglycerides [20-days]: Capillary blood triglycerides - mmol/L

Secondary outcomes

  • Systolic blood pressure [Baseline]: Systolic blood pressure - measured using a digital blood pressure monitor
  • Systolic blood pressure [20-days]: Systolic blood pressure - measured using a digital blood pressure monitor
  • Diastolic blood pressure [Baseline]: Diastolic blood pressure - measured using a digital blood pressure monitor
  • Diastolic blood pressure [20-days]: Diastolic blood pressure - measured using a digital blood pressure monitor
  • Percent bodyfat [Baseline]: Participants percentage composition of fat - measured using bio-electrical impedance
  • Percent bodyfat [20-days]: Participants percentage composition of fat - measured using bio-electrical impedance
  • Waist to hip ratio [Baseline]: Ratio of waist to hip circumference - measured using anthropocentric tape
  • Waist to hip ratio [20-days]: Ratio of waist to hip circumference - measured using anthropocentric tape
  • Blood glucose [Baseline]: Capillary blood glucose - mmol/L
  • Blood glucose [20-days]: Capillary blood glucose - mmol/L
  • Triglyceride glucose index [Baseline]: Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
  • Triglyceride glucose index [20-days]: Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
  • Blood cholesterol - Total [Baseline]: Capillary blood cholesterol - mmol/L
  • Blood cholesterol - Total [20-days]: Capillary blood cholesterol - mmol/L
  • Blood cholesterol - LDL [Baseline]: Capillary blood cholesterol - mmol/L
  • Blood cholesterol - LDL [20-days]: Capillary blood cholesterol - mmol/L
  • Blood cholesterol - HDL [Baseline]: Capillary blood cholesterol - mmol/L
  • Blood cholesterol - HDL [20-days]: Capillary blood cholesterol - mmol/L
  • Coop-Wonka chart [Baseline]: Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
  • Coop-Wonka chart [20-days]: Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
  • Beck Depression Inventory [Baseline]: 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.
  • Beck Depression Inventory [20-days]: 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.
  • State Trait Anxiety Inventory [Baseline]: 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.
  • State Trait Anxiety Inventory [20-days]: 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.
  • Insomnia Severity Index [Baseline]: 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.
  • Insomnia Severity Index [20-days]: 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.
  • Pittsburgh Sleep Quality Index [Baseline]: 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.
  • Pittsburgh Sleep Quality Index [20-days]: 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.
  • Epworth Sleepiness Scale [Baseline]: 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.
  • Epworth Sleepiness Scale [20-days]: 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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy
* Between 18 \& 65 years
* Non-smoker
* BMI < 30
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to berberine
* Habitual consumption of berberine
* Not regularly taking medication or antioxidant supplements

My Notes