Clinical trial NCT06490133: Evaluation of Consuming Olive Extract on Total Cholesterol Levels
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome &#X7C; Serum or Plasma &#X7C; Chemistry - Non-Challenge
Overweight
Keywords: polyhpenols from olives
metabolic syndrome
cholesterol
lifestyle
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups double blind, 12-week nutritional intervention
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total cholesterol
timeFrame: Baseline
measure: Total cholesterol
timeFrame: 12 weeks
measure: HDL cholesterol
timeFrame: Baseline
measure: HDL cholesterol
timeFrame: 12 weeks
measure: LDL cholesterol
timeFrame: Baseline
measure: LDL cholesterol
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: Baseline
measure: Triglycerides
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: Baseline
measure: Weight
timeFrame: 12 weeks
measure: Fat mass
timeFrame: Baseline
measure: Fat mass
timeFrame: 12 weeks
measure: Hemoglobin
timeFrame: Baseline
measure: Hemoglobin
timeFrame: 12 weeks
measure: Hematocrit
timeFrame: Baseline
measure: Hematocrit
timeFrame: 12 weeks
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: 12 weeks
measure: Dietary intake
timeFrame: Baseline
measure: Dietary intake
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Centro de Investigacion en Nutricion. Universidad de Navarra
state: Navarra
Study officials:
References: