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Completed

NCT Number: NCT06490133

Evaluation of Consuming Olive Extract on 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.

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Key information

Conditions

Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigacion en Nutricion. Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polyhpenol extract

Dietary Supplement

Three capsules in fasting conditions 15 minutes prior breakfast

Placebo

Dietary Supplement

Three capsules in fasting conditions 15 minutes before breakfast

Primary outcomes

  1. Total cholesterol

    Time frame: Baseline

    Serum concentration of Total Cholesterol

  2. Total cholesterol

    Time frame: 12 weeks

    Serum concentration of Total Cholesterol

  3. HDL cholesterol

    Time frame: Baseline

    Serum concentration of HDL cholesterol

  4. HDL cholesterol

    Time frame: 12 weeks

    Serum concentration of HDL cholesterol

  5. LDL cholesterol

    Time frame: Baseline

    Serum Calculated LDL Cholesterol levels

  6. LDL cholesterol

    Time frame: 12 weeks

    Serum Calculated LDL Cholesterol levels

  7. Triglycerides

    Time frame: Baseline

    Serum Triglycerides levels

  8. Triglycerides

    Time frame: 12 weeks

    Serum Triglycerides levels

Secondary outcomes

  1. Weight

    Time frame: Baseline

    Weight status

  2. Weight

    Time frame: 12 weeks

    Weight status

  3. Fat mass

    Time frame: Baseline

    Fat mass in kg, measured by Bioimpedance

  4. Fat mass

    Time frame: 12 weeks

    Fat mass in kg, measured by Bioimpedance

  5. Hemoglobin

    Time frame: Baseline

    Hemoglobin measured as mg/dL

  6. Hemoglobin

    Time frame: 12 weeks

    Hemoglobin measured as mg/dL

  7. Hematocrit

    Time frame: Baseline

    Hematocrit (%)

  8. Hematocrit

    Time frame: 12 weeks

    Hematocrit (%)

  9. Physical Activity

    Time frame: Baseline

    Measured through the IPAQ questionnaire

  10. Physical Activity

    Time frame: 12 weeks

    Measured through the IPAQ questionnaire

  11. Blood pressure

    Time frame: Baseline

    Measured in the dominant arm (mmHg)

  12. Blood pressure

    Time frame: 12 weeks

    Measured in the dominant arm (mmHg)

  13. Dietary intake

    Time frame: Baseline

    FFQ from the SUN Study

  14. Dietary intake

    Time frame: 12 weeks

    FFQ from the SUN Study

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

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

Acronym: OLICOL

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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