Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Pathology
• Intervention / Treatment: Dietary supplement: HT treatment; Dietary supplement: Placebo treatment

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia (UCAM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HT treatment; Every caramel contained 15 mg of HT, cyclodextrins and xylitol. Patients consumed 4 caramels/day, totalling 60 mg of HT/day.	Dietary supplement: HT treatment; Total consumption of 60 mg/day of HT; Other Names: Hydroxytyrosol
Placebo Comparator: Placebo treatment; Every caramel contained cyclodextrins and xylitol. Patients consumed 4 caramels/day.	Dietary supplement: Placebo treatment; Consumption of placebo treatment of 4 caramels/day; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cardiovascular risk; randomized; crossover; hydroxytyrosol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; 3,4-dihydroxyphenylethanol
• Other Study ID Numbers: HT-UCAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No