Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485349
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-06-14
Brief Title:
Olive Leaf Extract Meta-inflammation Anxiety and Excess Weight
Sponsor:
University of Guadalajara
Organization:
University of Guadalajara
Study Overview
Official Title:
Olive Leaf Extract Effects on Meta-inflammation and Anxiety Symptoms in Women With Excess Weight
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 kgm2 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 mgday 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 patients 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
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 mgday 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None