Olive Leaf Extract Effects on Meta-inflammation and Anxiety Symptoms in Women With Excess Weight
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in TNF-α concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blinded control
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change in TNF-α concentration
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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 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 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).)
- 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).)
- 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).)
- 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).)
- 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).)
研究者
Ma. Sonia Luquín de Anda
Principal Investigator, Head of Neuroscience Department
University of Guadalajara