Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile (NCT07514663) | Clinical Trial Compass
RecruitingNot Applicable
Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile
United States54 participantsStarted 2026-04-10
Plain-language summary
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).
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Known allergy or sensitivity to study product or any ingredients of the study product or assigned meals/snacks/beverages provided.
What they're measuring
1
Non-high density lipoprotein cholesterol (non-HDL-C)
Timeframe: Baseline (day 0) to end of each condition (day 21)
Trial details
NCT IDNCT07514663
SponsorMidwest Center for Metabolic and Cardiovascular Research
. 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).
✕. 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 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.
✕. History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
✕. Unstable use (defined as initiation or change in dosage) of anti-hypertensive medication within 12 weeks of visit 1 (day -7).