Clinical trial NCT06485349: Olive Leaf Extract, Meta-inflammation, Anxiety, and Excess Weight
Official title: Olive Leaf Extract Effects on Meta-inflammation and Anxiety Symptoms in Women With Excess Weight
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Women
Excess Weight
Anxiety Disorders
Keywords: Olive leaf extract
Women
Meta-inflammation
Anxiety
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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 criteria: age ≥18- ≤40 years, body mass index (BMI) ≥25- ≤40 kg/m\^2, blood pressure ≤ 129 mmHg systolic and ≤80 diastolic; anxiety symptomatology score 6 to 14 (mild) according to Hamilton Anxiety Scale (HAS).

70 women at the University Center for Health Sciences (CUCS) from Universidad de Guadalajara who meet inclusion criteria will be invited to participate. Two groups will be randomly formed consisting of 35 women with excessive weight and anxious symptoms each (by the BMI and HAS score, respectively); 35 will receive cellulose (100 mg) as a placebo, and the other 35, 750 mg/day of Olive Leaf Extract (OLE) orally, daily, for 90 days. Participants would be instructed to consume it after breakfast without modifying their eating patterns.

Anxious symptomatology will be measured by HAS and Beck Anxiety Inventory (BAI), alternately, every 30 days for 90 days; at the beginning, it would be HAS, after 30 days, investigators will apply BAI, then, after the next thirty days HAS (day 60) and, finally, will end the study applying BAI (day 90). Alternation of these tests is done to avoid bias in patients that allows them to recognize answers to obtain better scores.

Treatment adherence will be reviewed on a biweekly basis. At the same time, biweekly, participants will have to fill out a nutritional 24-hour food recall and a food frequency questionnaire and will also be asked if it is their desire to keep participating or not in the investigation.

To evaluate meta-inflammation, levels of leptin, IL-6, TNF-α, and cortisol in serum will be quantified using the ELISA technique. This will be done by doing a blood extraction at the beginning and another one at the end of the study (day 90). These two extractions will also be used to measure the patient's lipid profile (LDL cholesterol; LDL-c, total cholesterol; TC, triglycerides; TG and HDL-cholesterol; HDL-c) and glycosylated hemoglobin.

At the beginning of the study, investigators will apply a nutritional clinic history that contains information on eating habits (24-hour recall and food frequency), clinical history, and family health history. Anthropometric parameters such as weight, height, age, and BMI will be recorded; also, the percentage of body fat and muscle through bioimpedance. Height will be measured with a stadiometer. Weight and components associated with excessive weight such as percentage of body fat and muscle will be recorded monthly using an Omron® HBF-514C bioimpedance scale.

Eligibility criteria: 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 outcomes:
measure: Change in TNF-α concentration
timeFrame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
measure: Change in IL-6 concentration
timeFrame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
measure: Change in leptine concentration
timeFrame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
measure: Change in cortisol concentration
timeFrame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
measure: Change in Anxiety symptomatology scored by Hamilton Anxiety Scale (HAS)
timeFrame: From baseline, day 0, pre-supplementation, up to day 60, during supplementation. It will be applied bimonthly, twice in total.
measure: Change in Anxiety symptomatology scored by Beck Anxiety Index (BAI)
timeFrame: 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:
measure: Change in weight
timeFrame: 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).
measure: Change in body fat percentage
timeFrame: 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).
measure: Change in body muscle percentage
timeFrame: 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).
measure: Change in lipid profile
timeFrame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
measure: Change in glycosylated hemoglobin
timeFrame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
measure: 24 hour dietary intake recall
timeFrame: 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).
measure: Food Frequency Questionnaire
timeFrame: 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).
measure: Change in BMI
timeFrame: 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).
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Ma. Sonia Luquin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: