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

NCT07514663 | Recruiting

• 1 other identifier: MB-2546
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Non-high density lipoprotein cholesterol (non-HDL-C)

  Percentage change in non-HDL-C concentration

  Baseline (day 0) to end of each condition (day 21)

Secondary Outcomes (9)

• Total Cholesterol

  Baseline (day 0) to end of each condition (day 21)

• Low-density lipoprotein cholesterol (LDL-C)

  Baseline (day 0) to end of each condition (day 21)

• High-density lipoprotein cholesterol (HDL-C)

  Baseline (day 0) to end of each condition (day 21)

• Triglycerides

  Baseline (day 0) to end of each condition (day 21)

• Apolipoprotein B

  Baseline (day 0) to end of each condition (day 21)

Study Arms (2)

Corn Oil

EXPERIMENTAL

Corn oil (4 tablespoons/d) will be provided in 3 servings of study products per day (yogurt, dinner roll, and muffin).

Other: corn oil

Avocado Oil

ACTIVE COMPARATOR

Avocado oil (4 tablespoons/d) will be provided in 3 servings of study products per day (yogurt, dinner roll, and muffin).

Other: Avocado Oil

Interventions

corn oil OTHER

Corn oil will be provided in yogurt, rolls and muffins throughout the study period.

Corn Oil

Avocado Oil OTHER

Avocado oil will be provided in yogurt, rolls and muffins throughout the study period.

Avocado Oil

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• If a smoker, subject has no plans to change smoking habits during the study period.
• 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.

You may not qualify if:

• 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).
• 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).
• Use of beta-adrenergic blockers and/or high-dose (\>25 mg/d) thiazide diuretics within 4 weeks of visit 1 (day -7).
• Unstable use (defined as initiation or change in dose) of any thyroid hormone replacement within 12 weeks of visit 1 (day -7).
• Unstable use (defined as initiation or change in dosage, agent, or regimen) of statin medication within 12 weeks of visit 1 (day -7).
• 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).
• 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.
• 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).
• 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).

Sponsors & Collaborators

• ACH Food Companies, Inc.: collaborator
• Midwest Center for Metabolic and Cardiovascular Research: lead

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Corn Oil

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Caryn Adams, MPH

CONTACT

630-469-6600; cwolfe@mbclinicalresearch.com

Sara Campbell, MPH

CONTACT

630-469-6600; scampbell@mbclinicalresearch.ocm

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 7, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)