Ragle Human Nutrition Center
Davis, California, 95616, United States
NCT Number: NCT04149288
The purpose of this research is to investigate whether consuming two different kinds of olive oil will change risk factors related to cardiovascular disease, including levels of good and bad cholesterol, levels of inflammation, and levels of gene expression.
This study is active but is not currently recruiting participants.
20 year–45 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
The purpose of this research is to investigate whether consuming two different kinds of olive oil will change risk factors related to cardiovascular disease, including levels of good and bad cholesterol, levels of inflammation, and levels of gene expression. Healthy individuals aged 20-45 with a BMI over 20 kg/m2 are eligible to participate. The study involves 5 visits (1 initial screening and 4 study visits) and will last about 8 weeks. There is a 2-week run-in period before starting the study, followed by two diet intervention periods each lasting two weeks, separated by a two-week washout period.
Participation in this study will involve an initial two-week run in period to become accustomed to the study diet. After this two week period, participants will be randomly selected to start either a high-polyphenol olive oil (extra virgin olive oil) or a low-polyphenol olive oil (refined olive oil); participants will consume the other oil during the second dietary intervention period lasting 2 weeks. During each phase of the study, participants will be asked to come to the University of California, Davis campus after a 10-12 hour overnight fast. At each visit, body measurements will be taken, a serving of olive oil and bread will be eaten, and three urine and blood samples will be collected over the course of 4 hours. Each study visit will involve three blood draws by a trained nurse or phlebotomist.
During the 8 weeks of the study, all olive products such as olives, olive oil, and olive containing products will need to be avoided. The study will provide olive oil to be eaten at home for each intervention phase. Additionally, the investigators will ask that nuts and high-polyphenol foods (mostly fruits and vegetables) be avoided in the diet. Detailed food diaries will be filled out and brought to study visits.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-polyphenol olive oil will be provided to study participants to consume at home. Participants will be asked to consume 40 mL each day for 2 weeks.
Low-polyphenol olive oil will be provided to study participants to consume at home. Participants will be asked to consume 40 mL each day for 2 weeks.
Time frame: Through study completion, an average of 8 weeks
Cholesterol efflux will be measured by assessing changes in reverse cholesterol transport rate in separated serum at each study time point (baseline, 2 hour, 4 hour) using a commercially available assay kit at each of the 4 study visits.
Time frame: Through study completion, an average of 8 weeks
Changes in CETP activity will be measured at each study time point (baseline, 2 hour, 4 hour) in plasma at each of the 4 study visits. The isolated plasma will be co-incubated with donor and acceptor molecules using a commercially available assay kit.
Time frame: Through study completion, an average of 8 weeks
Measure for changes in circulating levels of oxidized LDL in separated plasma at each study time point (baseline, 2 hour, 4 hour) using a commercially available ELISA kit; measured in units of U/L at each of the 4 study visits.
Time frame: Through study completion, an average of 8 weeks
Measure for changes in the levels of HDL and LDL in separated plasma; measured in units of mg/dL. Blood will be assessed for the fasting (baseline) sample only at each of the 4 study visits.
Time frame: Through study completion, an average of 8 weeks
Measure for changes in PON-1 activity in separated plasma at each study time point (baseline, 2 hour, 4 hour) at each of the 4 study visits. Activity will be calculated based on linear rates of hydrolysis of phenyl acetate to phenol.
Time frame: Through study completion, an average of 8 weeks
Measurement of changes in PBMC derived cytokines as a marker of inflammation at each study time point (baseline, 2 hour, 4 hour) at each of the 4 study visits. Assessment will be based on an increase or decrease in concentration in pg/ml.
Time frame: Through study completion, an average of 8 weeks
Measure level of gene expression in micro RNA from PBMCs at each study time point (baseline, 2 hour, 4 ) at each of the 4 study visits. Assessment will be based on fold change between study arms.
Time frame: Through study completion, an average of 8 weeks
Use a computer program to check for study dietary requirements. Subjects are to avoid olives and olive containing products during study protocol periods. This will be done using a subject self-recorded 3-day food record submitted to study personnel.
Time frame: Through study completion, an average of 8 weeks
Measure waist (cm) and hip circumference (cm) before the start of drawing blood on study day protocols.
Time frame: Through study completion, an average of 8 weeks
Measure weight (kg) before the start of drawing blood on study day protocols.
Time frame: Through study completion, an average of 8 weeks
Measure blood pressure (mmHg) before the start of drawing blood on study day protocols.
Time frame: Through study completion, an average of 8 weeks
Measure circulating cytokines in separated plasma at each study time point (baseline, 2 hour, 4 hour) at each of the 4 study visits. Commercially available ELISA kits will be used: TNF-a, IL-6, IL-1B, MCP-1, and ET-1.
Time frame: Through study completion, an average of 8 weeks
Metabolomics will be performed on urine to assess for study compliance of consumption of the polyphenol containing olive oil versus the low-polyphenol containing olive oil at each of the 4 study visits.
University of California, Davis
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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