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.
Known allergy or sensitivity to study product or any ingredients of the study product or assigned meals/snacks/beverages provided.
Abnormal laboratory test results of clinical significance. One retest may be allowed on a case-by-case basis at the discretion of the Investigator.
Fasting blood glucose ≥126 mg/dL at screening or known type 1 or type 2 diabetes mellitus.
Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure. One re-test will be allowed on a separate day prior to visit 2 (day 0) for participants whose blood pressure exceeds either of these cut points at visit 1 (day -7).
Midwest Center for Metabolic and Cardiovascular Research
Lead sponsor
ACH Food Companies, Inc.
Collaborator