NCT07541898

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 14, 2026

Last Update Submit

April 14, 2026

Conditions

Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Blood triglycerides

    Capillary blood triglycerides - mmol/L

    Baseline

  • Blood triglycerides

    Capillary blood triglycerides - mmol/L

    20-days

Secondary Outcomes (30)

  • Systolic blood pressure

    Baseline

  • Systolic blood pressure

    20-days

  • Diastolic blood pressure

    Baseline

  • Diastolic blood pressure

    20-days

  • Percent bodyfat

    Baseline

  • +25 more secondary outcomes

Study Arms (2)

Berberine tablets 500mg 2 x p/d

EXPERIMENTAL
Dietary Supplement: Berberine

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

BerberineDIETARY_SUPPLEMENT

Berberine supplement 500 mg 2 x per day

Berberine tablets 500mg 2 x p/d
PlaceboOTHER

Placebo control 2 x blinded placebo tablet per day

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Berberine

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Jonathan K Sinclair, PhD, DSc

CONTACT

01772892796jksinclair@lancashire.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share