Evaluation of Consuming Olive Extract on Total Cholesterol Levels

NCT06490133 | Completed

• 1 other identifier: OLICOL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

polyhpenols from olives; metabolic syndrome; cholesterol; lifestyle

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (14)

• Weight

  Baseline

• Weight

  12 weeks

• Fat mass

  Baseline

• Fat mass

  12 weeks

• Hemoglobin

  Baseline

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsules containing placebo.

Dietary Supplement: Placebo

Polyhpenol extract

EXPERIMENTAL

Capsules containing the experimental polyhpenol to be assayed

Dietary Supplement: Polyhpenol extract

Interventions

Polyhpenol extract DIETARY_SUPPLEMENT

Three capsules in fasting conditions 15 minutes prior breakfast

Polyhpenol extract

Placebo DIETARY_SUPPLEMENT

Three capsules in fasting conditions 15 minutes before breakfast

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Centro de Investigacion en Nutricion. Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Metabolic Syndrome; Overweight

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel groups double blind, 12-week nutritional intervention

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: April 3, 2024
• Primary Completion: September 8, 2024
• Study Completion: September 15, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)