Status:
COMPLETED
Evaluation of Consuming Olive Extract on Total Cholesterol Levels
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge
Overweight
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The main objective of this nutritional intervention is to assess the efficacy of polyphenol-rich capsules on reducing metabolic syndrome traits, mainly cholesterol levels. For this purpose, a double b...
Eligibility Criteria
Inclusion
- BMI between 25 and 35 Kg/m2
- 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
- Any alteration of the Gastrointestinal system, functional or structural (gastric ulcer, chronic inflammatory diseases, hernia, etc.)
- 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.
Key Trial Info
Start Date :
April 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06490133
Start Date
April 3 2024
End Date
September 15 2024
Last Update
December 9 2024
Active Locations (1)
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1
Centro de Investigacion en Nutricion. Universidad de Navarra
Pamplona, Navarre, Spain, 31008