Evaluation of Consuming Olive Extract on Total Cholesterol Levels (OLICOL)

University of Navarra

Status: Completed

Conditions: Overweight; Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge

Treatments: Dietary Supplement: Polyhpenol extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06490133

OLICOL

Details and patient eligibility

About

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 blind, placebo controlled study of 12 weeks will be carried out.

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Capsules containing placebo.

Treatment:

Dietary Supplement: Placebo

Polyhpenol extract

Experimental group

Description:

Capsules containing the experimental polyhpenol to be assayed

Treatment:

Dietary Supplement: Polyhpenol extract