Effects of Corn and Coconut Oils on Lipoprotein Lipids, Insulin Sensitivity and Inflammation
Healthy Men and Women
About this trial
This is an interventional supportive care trial for Healthy Men and Women
Eligibility Criteria
Inclusion Criteria:
- BMI of 18.5-34.9 kg/m2.
- Fasting LDL-C level ≥115 mg/dL and <190 mg/dL, and TG level ≤375 mg/dL.
- Judged to be in general good health on the basis of medical history and screening laboratory tests.
Exclusion Criteria:
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).
- History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type 1 or 2 diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
- Known allergy, sensitivity, or intolerance to any ingredients in the study products.
- Uncontrolled hypertension.
- Recent history of cancer, except for non-melanoma skin cancer.
- Recent change in body weight of ± 4.5 kg.
- Recent use of any medications intended to alter the lipid profile [e.g., statins, bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, or proprotein convertase subtilisin kexin type 9 inhibitors].
- Recent use of any foods or dietary supplement that might alter lipid metabolism [e.g., omega-3 fatty acid supplements (e.g., flaxseed, fish or algal oils) or fortified foods, sterol/stanol products; dietary supplements (including Metamucil® or viscous fiber-containing supplement); red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >400 mg/d].
- Recent use of weight-loss drugs or programs or antibiotics.
- Recent daily use of non-steroidal anti-inflammatory drugs (except low-dose aspirin) or unstable use of antihypertensive medication.
- Recent use of medications that influence carbohydrate metabolism (e.g., adrenergic receptor blockers, diuretics, hypoglycemic medications, and/or systemic corticosteroids).
- Pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Extreme dietary habits (e.g., vegan or very low carbohydrate diet).
- Current or recent history for drug or alcohol abuse.
- History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
- Exposure to any non-registered drug product.
Sites / Locations
- MB Clinical Research
- Great Lakes Clinical Trials
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Corn Oil Intervention
Coconut Oil Intervention
Study products delivering 4 tablespoons/day corn oil will be administered for 4-week treatment period.
Study products delivering 4 tablespoons/day coconut oil will be administered for 4-week treatment period.