A Randomized, Double-Blind, Controlled Feeding, Crossover Trial to Assess the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile in Men and Women
The goal of this clinical trial is to assess the effects of corn and avocado oils as part of controlled feeding diets on the cardiometabolic risk factor profile in men and women with mild-to-moderately elevated levels of non-high-density lipoprotein cholesterol (non-HDL-C). Participants will be asked to consume the controlled feeding diet for two separate 21 day conditions, and will consume their regular diet for a 21 day washout period between the two conditions. Additionally, participants will be asked to come into the clinic on 7 different occasions, including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 21-d diet condition (visits 3 \& 6, day 19 and visits 4 \& 7, day 21), and a visit at the conclusion of the washout phase/start of the second diet condition (visit 5, day 0).
• Male or female 18 - 74 years of age, inclusive.
• Body mass index ≥18.5 and \<35.0 kg/m2.
• Fasting non-HDL-C level ≥125 mg/dL and \<225 mg/dL.
• Fasting TG level \<500 mg/dL.
• Vein access scale score of 7-10.
• Judged by the Investigator to be in generally good health, based on medical history and screening measurements.
• Calculated energy needs of ≥1800 kcal/d per the Mifflin-St Jeor Equation, with an adjustment for energy expended in physical activity.
• Willing to consume only study-related foods/beverages during each 21-d condition and visit the clinic each weekday morning during this time.
• If a smoker, subject has no plans to change smoking habits during the study period.
⁃ Understands and is willing to complete the study procedures, including maintaining usual physical activity pattern and refraining from vigorous physical activity for 24 h prior to each clinic visit requiring a blood draw. Signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.