Effects of Berberine on Cardiometabolic Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Central Lancashire

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy

Between 18 & 65 years

Non-smoker

BMI < 30

Disqualifiers

Pregnancy

Diabetes or any other metabolic/ uncontrolled hypertensive conditions

Food allergies to berberine

Habitual consumption of berberine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Berberine

    Dietary supplement

    Berberine supplement 500 mg 2 x per day

  • Placebo

    Other intervention

    Placebo control 2 x blinded placebo tablet per day

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Berberine tablets 500mg 2 x p/dExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood triglycerides

Capillary blood triglycerides - mmol/L

Time frame
Baseline
2

Blood triglycerides

Capillary blood triglycerides - mmol/L

Time frame
20-days

Secondary outcomes

1

Systolic blood pressure

Systolic blood pressure - measured using a digital blood pressure monitor

Time frame
Baseline
2

Systolic blood pressure

Systolic blood pressure - measured using a digital blood pressure monitor

Time frame
20-days
3

Diastolic blood pressure

Diastolic blood pressure - measured using a digital blood pressure monitor

Time frame
Baseline
4

Diastolic blood pressure

Diastolic blood pressure - measured using a digital blood pressure monitor

Time frame
20-days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: