Status:

ENROLLING_BY_INVITATION

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

Lead Sponsor:

University of Guadalajara

Conditions:

Women

Excess Weight

Eligibility:

FEMALE

18-40 years

Phase:

NA

Brief 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 oxida...

Detailed Description

A randomized double-blind placebo clinical trial is proposed. Study groups will be comprised of women living with excessive weight from the Guadalajara Metropolitan Area who meet the following criteri...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 16 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2026

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT06485349

Start Date

October 16 2024

End Date

January 31 2026

Last Update

October 18 2024

Active Locations (1)

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1

Universidad de Guadalajara

Guadalajara, Jalisco, Mexico, 44340