Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile

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).

Inclusion Criteria:

1. Male or female 18 - 74 years of age, inclusive.
2. Body mass index ≥18.5 and <35.0 kg/m2.
3. Fasting non-HDL-C level ≥125 mg/dL and <225 mg/dL.
4. Fasting TG level <500 mg/dL.
5. Vein access scale score of 7-10.
6. Judged by the Investigator to be in generally good health, based on medical history and screening measurements.
7. Calculated energy needs of ≥1800 kcal/d per the Mifflin-St Jeor Equation, with an adjustment for energy expended in physical activity.
8. Willing to consume only study-related foods/beverages during each 21-d condition and visit the clinic each weekday morning during this time.
9. If a smoker, subject has no plans to change smoking habits during the study period.
10. 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.

Exclusion Criteria:

1. Known allergy or sensitivity to study product or any ingredients of the study product or assigned meals/snacks/beverages provided.
2. Abnormal laboratory test results of clinical significance. One retest may be allowed on a case-by-case basis at the discretion of the Investigator.
3. Fasting blood glucose ≥126 mg/dL at screening or known type 1 or type 2 diabetes mellitus.
4. 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).
5. Atherosclerotic cardiovascular disease, including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease (symptomatic [e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin] or >50% stenosis on angiography or ultrasound) or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
6. History or presence of a clinically significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary, pancreatic, neurologic, psychiatric, inflammatory or biliary disorder that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
7. History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
8. Unstable use (defined as initiation or change in dosage) of anti-hypertensive medication within 12 weeks of visit 1 (day -7).
9. Use of beta-adrenergic blockers and/or high-dose (>25 mg/d) thiazide diuretics within 4 weeks of visit 1 (day -7).
10. Unstable use (defined as initiation or change in dose) of any thyroid hormone replacement within 12 weeks of visit 1 (day -7).
11. Unstable use (defined as initiation or change in dosage, agent, or regimen) of statin medication within 12 weeks of visit 1 (day -7).
12. Use of any medications intended to alter the lipoprotein lipid profile, other than statins, including but not limited to, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, prescription omega-3 fatty acid drugs (e.g., icosapent ethyl), or proprotein convertase subtilisin/kexin 9 (PCSK9)-targeted therapy within 12 weeks of visit 1 (day -7).
13. Use of any foods or dietary supplement that might alter lipid metabolism, including but not limited to, omega-3 fatty acid dietary supplements (e.g., flaxseed, fish, or algal oils) or fortified foods, sterol/stanol products; red rice yeast supplements; garlic supplements; soy isoflavone supplements; and niacin or its analogues at doses >200 mg/d (or others at the discretion of the Investigator) within 2 weeks of visit 2 (day 0). A stable dose of any dietary fiber supplement, including Metamucil® or viscous fiber-containing supplement per day, is allowed.
14. Use of diabetes medications, including α-glucosidase inhibitors, biguanides and biguanide combinations, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, glucose-dependent insulinotropic polypeptide, meglitinides, sulfonylureas and sulfonylurea combinations, and thiazolidinediones, within 12 weeks of visit 1 (day -7).
15. Use of dietary supplements that may affect carbohydrate metabolism, including chromium picolinate, ginseng, cinnamon (as a dietary supplement), and starch blockers within 2 weeks of visit 2 (day 0).
16. Use of systemic corticosteroids within 4 weeks of visit 1 (day -7).
17. Use of prescribed weight-loss drugs or programs within 12 weeks prior to visit 1 (day -7).
18. Use of over-the-counter weight-loss medications, dietary supplements, or programs within 2 weeks prior to visit 2 (day 0).
19. Weight loss or gain >4.5 kg in the 3 months prior to visit 1 (day -7).
20. Extreme dietary habits (e.g., very-low-carbohydrate, vegetarian, vegan diets) in the opinion of the Investigator.
21. History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
22. Active infection or use of antibiotics within 5 d of any blood draw to measure lipoprotein lipid levels [Condition 1, visits 1 through 4 (days -7 through 21) and Condition 2, visits 5 through 7 (days 0 through 21)]. For those with an active infection and/or using antibiotics, participants must wait at least 5 d after the infection is resolved or antibiotic use is complete. The condition will be extended for completion of the controlled feeding period in these cases.
23. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
24. Positive urine drug screen for illicit drugs at visit 1.
25. Recent history of (within 12 months of screening; visit 1, day -7) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
26. Exposure to any non-registered drug product within 30 d prior to visit 1 (day -7).
27. Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.