Evaluation of Consuming Olive Extract on Total Cholesterol Levels

Not Applicable

Completed

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

• Registration Number: NCT06490133
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-05
• Study First Posted: 2024-07-08
• Status Verified: 2024-09
• Primary Completion: 2024-09-08
• Study Completion: 2024-09-15
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HDL cholesterol	12 weeks	Serum concentration of HDL cholesterol
Total cholesterol	12 weeks	Serum concentration of Total Cholesterol
LDL cholesterol	12 weeks	Serum Calculated LDL Cholesterol levels
Triglycerides	12 weeks	Serum Triglycerides levels

Secondary Outcome Measures

Name	Time	Method
Fat mass	12 weeks	Fat mass in kg, measured by Bioimpedance
Hemoglobin	12 weeks	Hemoglobin measured as mg/dL
Physical Activity	12 weeks	Measured through the IPAQ questionnaire
Blood pressure	12 weeks	Measured in the dominant arm (mmHg)
Dietary intake	12 weeks	FFQ from the SUN Study
Hematocrit	12 weeks	Hematocrit (%)
Weight	12 weeks	Weight status

Trial Locations

Locations (1)

Centro de Investigacion en Nutricion. Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain