Effects of Berberine on Cardiometabolic Outcomes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiometabolic Syndrome
• Intervention / Treatment: Dietary supplement: Berberine; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan K Sinclair, PhD, DSc; Phone Number: 01772892796; Email: jksinclair@lancashire.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo control 2 x blinded placebo tablet per day
Experimental: Berberine tablets 500mg 2 x p/d	Dietary supplement: Berberine; Berberine supplement 500 mg 2 x per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood triglycerides	Capillary blood triglycerides - mmol/L	Baseline
Blood triglycerides	Capillary blood triglycerides - mmol/L	20-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent bodyfat	Participants percentage composition of fat - measured using bio-electrical impedance	Baseline
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	Baseline
Blood glucose	Capillary blood glucose - mmol/L	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.	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.	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.	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.	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.	Baseline
Systolic blood pressure	Systolic blood pressure - measured using a digital blood pressure monitor	Baseline
Triglyceride glucose index	Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)	Baseline
Diastolic blood pressure	Diastolic blood pressure - measured using a digital blood pressure monitor	Baseline
Coop-Wonka chart	Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring	Baseline
Systolic blood pressure	Systolic blood pressure - measured using a digital blood pressure monitor	20-days
Diastolic blood pressure	Diastolic blood pressure - measured using a digital blood pressure monitor	20-days
Percent bodyfat	Participants percentage composition of fat - measured using bio-electrical impedance	20-days
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	20-days
Blood glucose	Capillary blood glucose - mmol/L	20-days
Triglyceride glucose index	Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)	20-days
Blood cholesterol - Total	Capillary blood cholesterol - mmol/L	Baseline
Blood cholesterol - Total	Capillary blood cholesterol - mmol/L	20-days
Blood cholesterol - LDL	Capillary blood cholesterol - mmol/L	Baseline
Blood cholesterol - LDL	Capillary blood cholesterol - mmol/L	20-days
Blood cholesterol - HDL	Capillary blood cholesterol - mmol/L	Baseline
Blood cholesterol - HDL	Capillary blood cholesterol - mmol/L	20-days
Coop-Wonka chart	Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring	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.	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.	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.	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.	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.	20-days

Collaborators and Investigators

• Sponsor: University of Central Lancashire
• Collaborators: DoNotAge.org

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Benzylisoquinolines; Berberine Alkaloids; Berberine
• Other Study ID Numbers: Berberine cardiometabolic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No