Olive Leaf Extract, Meta-inflammation, Anxiety, and Excess Weight
- Conditions
- WomenAnxiety DisordersExcess Weight
- Interventions
- Other: PlaceboDietary Supplement: Olive Leaf Extract (OLE)
- Registration Number
- NCT06485349
- Lead Sponsor
- University of Guadalajara
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 70
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 100mg cellulose with 250ml of water. Experimental Olive Leaf Extract (OLE) Olive Leaf Extract (OLE) Nutricost ® 750mg 20% oleuropein with 250ml of water.
- Primary Outcome Measures
Name Time Method Change in TNF-α concentration Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake). 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.
Change in IL-6 concentration Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake). 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
Change in leptine concentration Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake). 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
Change in Anxiety symptomatology scored by Beck Anxiety Index (BAI) 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. 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.
Change in cortisol concentration Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake). 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.
Change in Anxiety symptomatology scored by Hamilton Anxiety Scale (HAS) From baseline, day 0, pre-supplementation, up to day 60, during supplementation. It will be applied bimonthly, twice in total. 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.
- Secondary Outcome Measures
Name Time Method 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). Expressed in percentage (%). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment.
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). In kilograms (kg). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment.
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). 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.
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). 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 (%).
24 hour dietary intake recall 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). 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.
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). Expressed in percentage (%). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment.
Food Frequency Questionnaire 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). Taken on a biweekly basis to analyze their food consumption according to their group classification.
Change in BMI 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). 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.
Trial Locations
- Locations (1)
Universidad de Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico