Catholic University of Murcia (UCAM)
Murcia, 30107, Spain
NCT Number: NCT06319417
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Murcia, 30107, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total consumption of 60 mg/day of HT
Other names: Hydroxytyrosol
Consumption of placebo treatment of 4 caramels/day
Other names: Placebo
Time frame: up to 4 months
Evaluating the effect of HT caramels on cardiovascular biomarkers in blood samples (mg/dL)
Time frame: up to 2 months
Assessing the impact of HT caramels on cellular phenotype measured with flow cytometry
Universidad Católica San Antonio de Murcia
Other
Assessing the Impact of Hydroxytyrosol Caramel Treatment on the Cardiometabolic Health of Patients at Cardiovascular Risk Disease
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.
Published trials that share one or more normalized conditions with this study.
NCT04598685
Arterial Occlusive Diseases, Arteriosclerosis
Innsbruck, Tyrol, Austria
View Trial DetailsNCT01275963
Cardiomyopathies, Cardiovascular Diseases
Heidelberg, Germany
View Trial DetailsNCT04950218
Brain Diseases, Cardiovascular Diseases
Hellerup, Copenhagne, Denmark
View Trial Details