Evaluation of Consuming Olive Extract on Total Cholesterol Levels
NCT ID: NCT06490133
Last Updated: 2024-12-09
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
100 participants
INTERVENTIONAL
2024-04-03
2024-09-15
Brief Summary
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The target population is women and men with overweight or obesity. Researchers will compare the experimental capsules with placebo capsules, but will be blinded during the intervention and results analyses. Only after analysing the parameters, the groups will be revealed.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Capsules containing placebo.
Placebo
Three capsules in fasting conditions 15 minutes before breakfast
Polyhpenol extract
Capsules containing the experimental polyhpenol to be assayed
Polyhpenol extract
Three capsules in fasting conditions 15 minutes prior breakfast
Interventions
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Polyhpenol extract
Three capsules in fasting conditions 15 minutes prior breakfast
Placebo
Three capsules in fasting conditions 15 minutes before breakfast
Eligibility Criteria
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Inclusion Criteria
* Total Cholesterol levels in peripheral blood above or equal to 200 mg/dL or LDL-cholesterol levels above or equal to 160 mg/dL.
* Weight stability during the three months prior the start of the study (±5% of variation).
* To be able to attend the visits and accomplish with all the indications of the research staff.
* To have signed the written informed consent.
Exclusion Criteria
* Subjects having undergone any surgical operation in th egastrointestinal tract with permanent consequences (i.e. gastroduodenectomy).
* Subjects following any pharmacological treatment affecting gastric homeostasis.
* Suffer from any metabolic disease or cancer process.
* Being allergic to any of the compounds contained in the study capsules.
* Excessive alcohol ingestion (14 units/day for women, or 20 units/day for men).
* Women lactating or during pregnancy.
* Following any cholesterol-lowering treatment.
* People with any mental impairment or whose compliance with the study protocol is at risk.
18 Years
65 Years
ALL
Yes
Sponsors
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Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Locations
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Centro de Investigacion en Nutricion. Universidad de Navarra
Pamplona, Navarre, Spain
Countries
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Other Identifiers
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OLICOL
Identifier Type: -
Identifier Source: org_study_id