Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients

Not Applicable

Completed

• Conditions: Cardiovascular Pathology
• Interventions: Dietary Supplement: HT treatment; Dietary Supplement: Placebo treatment

• Registration Number: NCT06319417
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-04-15
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HT treatment	HT treatment	Every caramel contained 15 mg of HT, cyclodextrins and xylitol. Patients consumed 4 caramels/day, totalling 60 mg of HT/day.
Placebo treatment	Placebo treatment	Every caramel contained cyclodextrins and xylitol. Patients consumed 4 caramels/day.

Primary Outcome Measures

Name	Time	Method
Change of cardiovascular biomarkers	up to 4 months	Evaluating the effect of HT caramels on cardiovascular biomarkers in blood samples (mg/dL)
Change of cellular phenotype of platelets	up to 2 months	Assessing the impact of HT caramels on cellular phenotype measured with flow cytometry

Trial Locations

Locations (1)

Catholic University of Murcia (UCAM); 🇪🇸 Murcia, Spain