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

Nutritional Intervention to Evaluate the Effectiveness of the Consumption of Dehydrated Olive Pulp in Reducing Total Cholesterol Levels in Subjects with Overweight-obesity and High Total Cholesterol Levels

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Polyhpenol extract

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Centro de Investigacion en Nutricion. Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Capsules containing placebo.	Dietary supplement: Placebo; Three capsules in fasting conditions 15 minutes before breakfast
Experimental: Polyhpenol extract; Capsules containing the experimental polyhpenol to be assayed	Dietary supplement: Polyhpenol extract; Three capsules in fasting conditions 15 minutes prior breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol	Serum concentration of Total Cholesterol	Baseline
Total cholesterol	Serum concentration of Total Cholesterol	12 weeks
HDL cholesterol	Serum concentration of HDL cholesterol	Baseline
HDL cholesterol	Serum concentration of HDL cholesterol	12 weeks
LDL cholesterol	Serum Calculated LDL Cholesterol levels	Baseline
LDL cholesterol	Serum Calculated LDL Cholesterol levels	12 weeks
Triglycerides	Serum Triglycerides levels	Baseline
Triglycerides	Serum Triglycerides levels	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): September 8, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: metabolic syndrome; cholesterol; lifestyle; polyhpenols from olives
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Overweight; Metabolic Syndrome
• Other Study ID Numbers: OLICOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No