Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06319417 |
| Other study ID # |
HT-UCAM |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2022 |
| Est. completion date |
March 23, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Universidad Católica San Antonio de Murcia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
