Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients
NCT ID: NCT06319417
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2022-04-15
2023-03-23
Brief Summary
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* 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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
TREATMENT
DOUBLE
Study Groups
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HT treatment
Every caramel contained 15 mg of HT, cyclodextrins and xylitol. Patients consumed 4 caramels/day, totalling 60 mg of HT/day.
HT treatment
Total consumption of 60 mg/day of HT
Placebo treatment
Every caramel contained cyclodextrins and xylitol. Patients consumed 4 caramels/day.
Placebo treatment
Consumption of placebo treatment of 4 caramels/day
Interventions
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HT treatment
Total consumption of 60 mg/day of HT
Placebo treatment
Consumption of placebo treatment of 4 caramels/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elevated glucose level: \>100 mg/dL
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Universidad Católica San Antonio de Murcia
OTHER
Responsible Party
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LUIS TEJADA PORTERO
Researcher
Locations
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Catholic University of Murcia (UCAM)
Murcia, , Spain
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HT-UCAM
Identifier Type: -
Identifier Source: org_study_id
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