Actively Recruiting
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
Led by Midwest Center for Metabolic and Cardiovascular Research · Updated on 2026-04-17
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Midwest Center for Metabolic and Cardiovascular Research
Lead Sponsor
A
ACH Food Companies, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of corn oil and avocado oil on heart and metabolic health in adults with mildly to moderately high levels of non-HDL cholesterol. The study focuses on how these oils, included in controlled diets, influence factors related to heart disease risk. This is a randomized, double-blind, controlled feeding crossover trial involving men and women aged 18 to 74 with specific cholesterol levels. Participants will consume controlled diets containing either corn oil or avocado oil for two separate 21-day periods, separated by a 21-day washout phase where they eat their regular diet. Each oil is provided in three daily servings incorporated into yogurt, dinner rolls, and muffins, delivering 4 tablespoons per day. The study includes a screening visit, baseline visit, multiple visits during each diet phase, and a visit at the end of the washout period before the second diet begins. Throughout the study, participants will visit the clinic seven times for assessments including blood draws to measure cholesterol types, triglycerides, insulin resistance, and other metabolic markers. Researchers will monitor adherence to the diets, physical activity, and health status. The primary outcome is the change in non-HDL cholesterol from baseline to the end of each diet condition, with additional measures of other cholesterol types and insulin sensitivity. The total duration of participation covers about 10 weeks including all visits and diet phases.
CONDITIONS
Brief Title
Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 74 years, inclusive
- Body mass index between 18.5 and less than 35.0 kg/m2
- Fasting non-HDL cholesterol between 125 and less than 225 mg/dL
- Fasting triglycerides less than 500 mg/dL
- Vein access scale score of 7 to 10
- Generally good health based on medical history and screening
- Calculated energy needs of 1800 kcal/day or more
- Willingness to consume only study foods and beverages during each 21-day diet phase
- No plans to change smoking habits during the study if a smoker
- Ability to understand and complete study procedures including informed consent
You will not qualify if you...
- Allergy or sensitivity to study products or ingredients
- Abnormal laboratory test results of clinical significance
- Fasting blood glucose 126 mg/dL or higher or known diabetes
- Uncontrolled hypertension (systolic ≥160 mm Hg or diastolic ≥100 mm Hg)
- Atherosclerotic cardiovascular disease or related clinical signs
- Significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary, pancreatic, neurologic, psychiatric, inflammatory, or biliary disorders
- Cancer within past 2 years except non-melanoma skin cancer
- Recent unstable use of anti-hypertensive, beta-blockers, high-dose diuretics, thyroid hormones, statins, or lipid-altering medications
- Use of dietary supplements or medications affecting lipid or carbohydrate metabolism within specified timeframes
- Recent use of systemic corticosteroids or weight-loss drugs or programs
- Weight change greater than 4.5 kg in past 3 months
- Extreme dietary habits or diagnosed eating disorders
- Active infection or recent antibiotic use
- Pregnancy, lactation, or unwillingness to use contraception if of childbearing potential
- Positive urine drug screen
- Recent alcohol or substance abuse
- Exposure to non-registered drug products
- Any other condition interfering with informed consent or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days per diet phase
Participants consume study foods containing either corn oil or avocado oil in yogurt, dinner roll, and muffin servings during each diet phase.
2 diet phases with assessments at the start and end of each phase
Trial Site Locations
Total: 1 location
1
Biofortis Clinical Research
Addison, Illinois, United States, 60101
Actively Recruiting
Research Team
C
Caryn Adams, MPH
S
Sara Campbell, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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