Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients

NCT06319417 | Completed

• 1 other identifier: HT-UCAM
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Pathology

Keywords

hydroxytyrosol; cardiovascular risk; crossover; randomized

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

HT treatment

EXPERIMENTAL

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

Placebo treatment

PLACEBO COMPARATOR

Every caramel contained cyclodextrins and xylitol. Patients consumed 4 caramels/day.

Dietary Supplement: Placebo treatment

Interventions

HT treatment DIETARY_SUPPLEMENT

Total consumption of 60 mg/day of HT

Also known as: Hydroxytyrosol

HT treatment

Placebo treatment DIETARY_SUPPLEMENT

Consumption of placebo treatment of 4 caramels/day

Also known as: Placebo

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia (UCAM)

Murcia, 30107, Spain

Location

Related Publications (1)

• Noguera-Navarro C, Vinten KT, Aunon-Calles D, Carazo-Diaz C, Janssens GE, Montoro-Garcia S. Multi-omic analysis and platelet function distinguish treatment responses to hydroxytyrosol in cardiovascular risk. Food Funct. 2025 Jul 14;16(14):5928-5948. doi: 10.1039/d5fo00874c.

  PMID: 40619979 DERIVED

MeSH Terms

Interventions

3,4-dihydroxyphenylethanol

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Nor participant and care provider knew the treatment given.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 28 days of treatment: one group with HT treatment and the other with placebo treatment. 2-weeks washout period. The treatment will be switched between groups for another 28 days: those who initially consumed HT will the switch to the placebo treatment, and vice versa.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 20, 2024
• Study Start: April 15, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)