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Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients

NCT06319417 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-03-20

No results posted yet for this study

Summary

The goal of this double-blind crossover randomized clinical trial is to evaluate the impact of a phenolic natural compound called hydroxytyrosol (HT) on patients at cardiovascular risk (CVR). The main questions it aims to answer are:

* Evaluating the effect of HT caramels on CVR biomarkers.
* Assessing the impact of HT caramels on cellular phenotype.

Participants will take 4 caramels/day, each containing 15 mg of HT, consuming a daily intake of 60 mg for 28 days. One group will begin with HT caramel consumption for 28 days, while the other group will start with a placebo treatment. Following a 2-week washout period, the treatments will be switched between the groups. Those who initially consumed HT will then switch to the placebo treatment, and vice-versa, each for a duration of 28 days.

Conditions

  • Cardiovascular Pathology

Interventions

DIETARY_SUPPLEMENT

HT treatment

Total consumption of 60 mg/day of HT

DIETARY_SUPPLEMENT

Placebo treatment

Consumption of placebo treatment of 4 caramels/day

Sponsors & Collaborators

  • Universidad Católica San Antonio de Murcia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2023-03-23
Completion
2023-03-23

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319417 on ClinicalTrials.gov