Olive Leaf Extract, Meta-inflammation, Anxiety, and Excess Weight
NCT Number: NCT06485349
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Women|Excess Weight|Anxiety Disorders
Interventions: DIETARY_SUPPLEMENT: Olive Leaf Extract (OLE)|OTHER: Placebo
Sponsor: University of Guadalajara
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-05
Completion Date: 2026-01-31
Locations: Universidad de Guadalajara, Guadalajara, Jalisco, 44340, Mexico

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.

Primary Outcome Measures: 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 Outcome Measures: Change in weight, In kilograms (kg). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment., 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, Expressed in percentage (%). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment., 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, Expressed in percentage (%). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment., 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, Total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein: Blood serum would be taken from the participants after an overnight fast of 12 h; lipid profiles (triglycerides, total cholesterol, HDL-C, and LDL-C) would be determined using a piece of semi-automated equipment (Mindray-BS-240 Clinical Chemistry Analyzer, Shenzhen, China) and colorimetric enzymatic assays (BioSystems® kits, Barcelona, Spain). Measured in mg/dl., 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, Blood serum would be taken from the participants after an overnight fast of 12 h; glycosylated hemoglobin would be determined using a piece of semi-automated equipment (Mindray-BS-240 Clinical Chemistry Analyzer, Shenzhen, China) and colorimetric enzymatic assays (BioSystems® kits, Barcelona, Spain). Measured in percentage (%)., Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).|24 hour dietary intake recall, Taken on a biweekly basis to analyze the dietary intake consumed the previous day and measure their approximate caloric intake and macronutrient relationship with the Mexican Food Equivalent System., Its first application will be on day 15, during supplementation. Then, it will be applied on a biweekly basis, meaning day 30, day 45, day 60, day 75 up to day 90 (24 hours after the last supplement/placebo intake).|Food Frequency Questionnaire, Taken on a biweekly basis to analyze their food consumption according to their group classification., Its first application will be on day 15, during supplementation. Then, it will be applied on a biweekly basis, meaning day 30, day 45, day 60, day 75 up to day 90 (24 hours after the last supplement/placebo intake).|Change in BMI, Weight and height will be combined to report BMI in kg/m\^2 and it will be measured every month according to their actual weight-height relation., 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).