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