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

NCT06485349 | Enrolling By Invitation DMC

• 1 other identifier: 24-11
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Women; Excess Weight; Anxiety Disorders

Keywords

Olive leaf extract; Women; Meta-inflammation; Anxiety

Outcome Measures

Primary Outcomes (6)

• Change in TNF-α concentration

  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.

  Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).

• Change in IL-6 concentration

  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

  Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).

• Change in leptine concentration

  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

  Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).

• Change in cortisol concentration

  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.

  Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).

• Change in Anxiety symptomatology scored by Hamilton Anxiety Scale (HAS)

  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.

  From baseline, day 0, pre-supplementation, up to day 60, during supplementation. It will be applied bimonthly, twice in total.

• Change in Anxiety symptomatology scored by Beck Anxiety Index (BAI)

  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.

  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.

Secondary Outcomes (8)

• Change in weight

  From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).

• Change in body fat percentage

  From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).

• Change in body muscle percentage

  From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).

• Change in lipid profile

  Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).

• Change in glycosylated hemoglobin

  Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).

Study Arms (2)

Experimental

EXPERIMENTAL

Olive Leaf Extract (OLE) Nutricost ® 750mg 20% oleuropein with 250ml of water.

Dietary Supplement: Olive Leaf Extract (OLE)

Placebo

PLACEBO COMPARATOR

100mg cellulose with 250ml of water.

Other: Placebo

Interventions

Olive Leaf Extract (OLE) DIETARY_SUPPLEMENT

Daily dose of 750mg OLE consumed with water after breakfast without any modification of their dietary patterns for 90 days.

Also known as: Olive leaf extract Nutricost ® 750mg 20% oleuropein

Experimental

Placebo OTHER

100mg microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

olive leaf extract; oleuropein

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ma. Sonia Luquin, Ph.D

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded control
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Neuroscience Department

Model Details: Excess-weight women with mild anxiety symptomatology will be assigned in a control double-blind and randomized manner to one of two groups: olive leaf extract (OLE) (n=35) 750 mg 20% oleuropein or placebo (n=35). Participants would have sessions biweekly: 1. (Day 0, 30, 60, and 90): Anxious symptomatology, weight, height, body fat, and muscle percentage (blood extraction at day 0 and day 90). 2. (Day 15, 45, 75): Adherence, 24-hour recall, and Food frequency questionnaire (FFQ). Supplementation starts at day 0 and ends at day 89. Anxious symptomatology is evaluated, monthly, alternatively with the Hamilton Anxiety Scale (HAS) and Beck Anxiety Inventory (BAI). Adherence will be verified every 15 days as well as a 24-hour dietary recall and FFQ. ELISA assays will be used for TNF-α, IL-6, Cortisol, and leptin quantifications. It will be performed with 12h overnight fasting, in the morning; and lipid profile and glycosylated hemoglobin will be measured through biochemical tests.

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 3, 2024
• Study Start: October 16, 2024
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available approximately 3 months after publication and it will end its availability after 2 years of it. After that period, if requested, data should be asked to sonia.luquin@academicos.udg.mx or to mario.hernandez6110@alumnos.udg.mx, subject to availability.
• Access Criteria: The information will be available for research purposes to colleagues interested in the results of this study and whose information is useful to expand associated knowledge.

Locations

ME (1)