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Polyphenols
Olive Oil Polyphenols for Cardiovascular Health
N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 8 weeks
Awards & highlights
Study Summary
This trial will study the effects of two types of olive oil on cardiovascular disease risk factors.
Who is the study for?
This trial is for generally healthy men and women aged 20-45 with a BMI of 18.5-29.9 or ≥30 for obese individuals. Exclusions include smokers, heavy alcohol users, drug users, those unable to consent, pregnant/lactating women, people with high cholesterol or blood sugar levels, olive allergies, extreme diets/exercise habits, certain chronic diseases or medication use.Check my eligibility
What is being tested?
The study aims to see if consuming low-polyphenol versus high-polyphenol olive oil affects cardiovascular health markers like good/bad cholesterol levels, inflammation indicators and gene expression related to heart disease risk in healthy/overweight and obese participants.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include digestive discomfort due to changes in diet from introducing different types of olive oils.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessing the influence of olive oil polyphenols on blood lipid measurements
Assessing the influence of olive oil polyphenols on cholesterol efflux
Assessing the influence of olive oil polyphenols on cholesterol ester transfer protein activity (CETP)
+3 moreSecondary outcome measures
Assessing the influence of olive oil polyphenols on gene expression in mirco RNA in PBMCs
Other outcome measures
Anthropometric measurements
Assessing the influence of olive oil polyphenols on circulating cytokines
Assessing the influence of olive oil polyphenols on urine metabolites
+3 moreTrial Design
2Treatment groups
Active Control
Group I: High-polyphenol olive oilActive Control1 Intervention
Participants will consume 40 mL of high-polyphenol olive oil each day at home for 2 weeks.
Group II: Low-polyphenol olive oilActive Control1 Intervention
Participants will consume 40 mL of low-polyphenol olive oil each day at home for 2 weeks.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,947 Total Patients Enrolled
30 Trials studying Obesity
33,569 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic condition like diabetes, thyroid, kidney disease, or a history of heart issues.My weight has changed by more than 10% in the last 6 months.I am currently taking hormonal medications, like birth control.I am between 20-45 years old and my BMI is either in the healthy to overweight range or I am considered obese.You are allergic to olives, cannot eat food with gluten, or have many allergies that make it hard for you to eat a variety of foods.You have extreme eating or exercise habits.I have difficulty with blood draws or IV access.I am an adult who can consent, not pregnant, not planning pregnancy soon, and not imprisoned.I am taking medications or supplements that affect cholesterol or use more than 1g of fish oil/day, antioxidants, or CBD oil.I smoke, live with a smoker, use drugs, drink more than 1 alcoholic drink a day, or use vapes/e-cigarettes.I have had high cholesterol or blood sugar levels.
Research Study Groups:
This trial has the following groups:- Group 1: High-polyphenol olive oil
- Group 2: Low-polyphenol olive oil
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies within the parameters of this trial for volunteers?
"Clinicaltrials.gov reveals that this research project, which was initially posted on October 6th 2021, is currently recruiting participants. Most recently the trial was updated on October 31st 2022."
Answered by AI
Does the research allow for individuals below 65 years of age to partake?
"The prerequisites for recruitment into this trial specify the age range of participants must be between 20 and 45 years old."
Answered by AI
How many people have joined in on this research endeavor?
"Affirmative. Clinicaltrials.gov attests that this study is actively recruiting, having been first posted on October 6th 2021 and recently updated on October 31st 2022. The trial seeks to enrol 44 patients from 1 site in total."
Answered by AI
Can I qualify to be a participant in this clinical investigation?
"The study is enrolling 44 individuals between the ages of 20 and 45 who would be classified as overweight or obese according to BMI. The precise requirements include being a healthy male/female in the age range mentioned previously with a BMI ranging from 18.5-29.9 kg/m2 for those that are considered overweight, and ≥ 30 kg/m2 for those deemed to be obese."
Answered by AI
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