Study of the effects of a nutraceutical combination product including the antioxidant bergamot polyphenolic fraction in patients with high normal blood pressure

Study of the effects of a nutraceutical combination product including the antioxidant bergamot polyphenolic fraction in patients with high normal blood pressure: a double-blind, randomized, placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12850933

Enrollment

Registered

2024-11-19

Start date

2019-01-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High normal blood pressure (HNBP) and heart failure with preserved ejection fraction (HFpEF) Circulatory System

Interventions

A single-centre double-blind, randomized, placebo-controlled study will be conducted on a population of 60 subjects with HNBP and normal ejection fraction on echocardiographic examination, suffering f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with High Normal Blood Pressure (HNBP) and Heart Failure with preserved ejection fraction (HFpEF)

Exclusion criteria

Exclusion criteria: Patients with evidence of previous or current concomitant valvular disease

Design outcomes

Primary

Measure	Time frame
1. Cardiac performance measured using echocardiographic examination at baseline and day 90 2. Blood pressure measured using sphygmomanometry at baseline and day 90	—

Secondary

Measure	Time frame
Reduction of oxidative stress and endothelial dysfunction measured using endoPAT analysis and serum malondialdehyde (MDA) levels (a specific marker of oxidative stress) measured using the reactivity of thiobarbituric acid (TBA) as MDA used to assess oxidative stress through spectrophotometric quantification at baseline and day 90	—

Countries

Italy

Contacts

Public ContactRocco Mollace

rocco.mollace@gmail.com+39 3339156641

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026