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Clinical Trials in Mexico / NCT06485349
Enrolling by invitation Not applicable

Olive Leaf Extract, Meta-inflammation, Anxiety, and Excess Weight

NCT06485349 · tracked via the Priya Life Science Mexico tracker
Sponsor
University of Guadalajara
Phase
Not applicable
Started
2024-10-16
Last updated
2024-10-18

Condition(s) studied

WomenExcess WeightAnxiety Disorders

Investigational drug(s) / intervention(s)

Olive Leaf Extract (OLE)Placebo

Olive Leaf Extract (OLE): Daily dose of 750mg OLE consumed with water after breakfast without any modification of their dietary patterns for 90 days.

Placebo: 100mg microcrystalline cellulose

Study summary

Excess Weight is accompanied by a process that produces a low-grade inflammation state, called meta-inflammation. Anxiety is also associated with inflammation. Inflammation is closely related to oxidative stress. Both processes help perpetuate each other. Olive Leaf Extract (OLE) is known for having anti-inflammatory and antioxidant effects; by this means, its anxiolytic effect has been proved in animal models. The purpose of this investigation is to evaluate the anti-inflammatory and anxiolytic effects associated with the supplementation of OLE at a daily dose of 750mg (20% oleuropein) for 3 months.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Females. * Residing in Guadalajara Metropolitan Area (GMA). * Initial age ≥18-≤ 40 years * Initial Body Mass Index (BMI) ≥25-≤40 kg/m\^2 * Blood pressure: ≤129mmHg systolic and ≤80 diastolic. * Anxious symptomatology score 6 to 14 (mild) through the Hamilton Anxiety Scale (HAS). Exclusion Criteria: * Use of psychoactive drugs, suffering from major psychiatric disorders (depression, attention deficit hyperactivity disorder, bipolar disorder, eating disorders), pregnancy, breastfeeding, hypotension, alcohol use disorder (AUD). * Suffer from liver, kidney, or thyroid disease or cancer. * Olive allergy. * Consume any medication that influences weight * Consume some other type of food supplement from organic origin. * Less than 70% adherence frequency to the consumption of the extract/placebo. * Getting pregnant during the study.

Primary outcome measure(s)

  • Change in TNF-α concentration — Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
    Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human TNF-α ELISA kit; measured in pg/mL.
  • Change in IL-6 concentration — Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
    Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human IL-6 ELISA kit; measured in pg/mL
  • Change in leptine concentration — Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
    Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human leptin ELISA kit; measured in pg/mL
  • Change in cortisol concentration — Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
    Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human cortisol ELISA kit; measured in pg/mL.
  • Change in Anxiety symptomatology scored by Hamilton Anxiety Scale (HAS) — From baseline, day 0, pre-supplementation, up to day 60, during supplementation. It will be applied bimonthly, twice in total.
    Measured in accordance to the next score: 0-5, absence of anxiety; 6-14, mild anxiety; ≥15, moderate/severe anxiety, on an alternately, monthly, basis; in the morning in a peaceful controlled environment.
  • Change in Anxiety symptomatology scored by Beck Anxiety Index (BAI) — Its first application will be on day 30, during supplementation, up to day 90 (24 hours after the last supplement/placebo intake). It will be applied bimonthly, twice in total.
    Measured in accordance to the next score: 0-5, absence of anxiety; 6-15, mild anxiety; 16-30, moderate anxiety; 31-63 severe anxiety, on an alternately, monthly, basis; in the morning in a peaceful controlled environment.

Trial sites (1)

FacilityCityRegionStatus
Universidad de Guadalajara Guadalajara Jalisco

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Effect of a Food Supplement with Natural Extracts of Cocoa, Amaranth Seed and Ginger in Overweight or Obese Patients Active, not recruiting
INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06485349 on ClinicalTrials.gov ↗ ← All trials in Mexico