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Completed

NCT Number: NCT06319417

Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia (UCAM)

Murcia, 30107, Spain

About this study

A 10-week randomized, crossover, double-blind controlled clinical trial was conducted between April 2022 and March 2023 in the Catholic University of Murcia Randomization divided the participants in two groups, depending on whether they started consuming the caramels supplemented with HT, or the group that started consuming the placebo caramels.

The patients totally consumed 60 mg of HT per day distributed into 4 caramels/day with 15 mg of HT per caramel. The caramels in treatment group contained encapsulated HT in cyclodextrins, xylitol sweetened. On the other hand, the caramels in placebo group contained cyclodextrins and they were xylitol sweetened too. Patients were segregated into 2 groups: the ones who started as HT-group and the ones who started as C-group.

HT-group consumed HT caramels for 28 days, while C-group consumed placebo caramels followed by a 2-week washout period. Suddenly, groups were switched for 28 days, the ones who started as HT-group became C-group and vice-versa. The patients completely performed 4 visits during the study. In every appointment, they had blood and faeces extraction with body composition measurement. In addition, a Food Frequency Questionnaire (FFQ) based on Mediterranean Diet Serving Score (MDSS) was given to the patients in order to assess diet variability during the study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elevated cholesterol level: >200 mg/dL
  • Elevated glucose level: >100 mg/dL

Exclusion criteria

  • Not been under antihypertensive, antidiabetic and/or hypoglycaemic agents

Treatment and study plan

HT treatment

Dietary Supplement

Total consumption of 60 mg/day of HT

Other names: Hydroxytyrosol

Placebo treatment

Dietary Supplement

Consumption of placebo treatment of 4 caramels/day

Other names: Placebo

Primary outcomes

  1. Change of cardiovascular biomarkers

    Time frame: up to 4 months

    Evaluating the effect of HT caramels on cardiovascular biomarkers in blood samples (mg/dL)

  2. Change of cellular phenotype of platelets

    Time frame: up to 2 months

    Assessing the impact of HT caramels on cellular phenotype measured with flow cytometry

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Assessing the Impact of Hydroxytyrosol Caramel Treatment on the Cardiometabolic Health of Patients at Cardiovascular Risk Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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