HypercholesterolemiaNCT07514663
Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile
A study testing corn oil and Avocado Oil in people with Hypercholesterolemia, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- corn oil and Avocado Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- Use of systemic corticosteroids within 4 weeks of visit 1 (day -7).
- Use of prescribed weight-loss drugs or programs within 12 weeks prior to visit 1 (day -7).
- Use of over-the-counter weight-loss medications, dietary supplements, or programs within 2 weeks prior to visit 2 (day 0).
- Weight loss or gain >4.5 kg in the 3 months prior to visit 1 (day -7).
- Extreme dietary habits (e.g., very-low-carbohydrate, vegetarian, vegan diets) in the opinion of the Investigator.
- History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
- 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.
- 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.
- Positive urine drug screen for illicit drugs at visit 1.
- 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).
- Exposure to any non-registered drug product within 30 d prior to visit 1 (day -7).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Biofortis Clinical Research
Addison, Illinois, 60101
Gina Castiglione-Berg, (630) 617-2000, gina.castiglione-berg@msxn.com
About this study
Official title: 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).
- Conditions
- Hypercholesterolemia
- Being tested
- corn oil, Avocado Oil
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corn oilOther
Corn oil will be provided in yogurt, rolls and muffins throughout the study period.
Avocado OilOther
Avocado oil will be provided in yogurt, rolls and muffins throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Corn Oil | Experimental | Corn oil (4 tablespoons/d) will be provided in 3 servings of study products per day (yogurt, dinner roll, and muffin). Receives: 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). Receives: Other: Avocado Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-high density lipoprotein cholesterol (non-HDL-C)
Percentage change in non-HDL-C concentration
Measured: Baseline (day 0) to end of each condition (day 21)
Secondary outcomes (9)
Total Cholesterol
Percentage change in total cholesterol
Measured: Baseline (day 0) to end of each condition (day 21)
Low-density lipoprotein cholesterol (LDL-C)
Percentage change in low-density lipoprotein cholesterol (LDL-C)
Measured: Baseline (day 0) to end of each condition (day 21)
High-density lipoprotein cholesterol (HDL-C)
Percentage change in high-density lipoprotein cholesterol (HDL-C)
Measured: Baseline (day 0) to end of each condition (day 21)
Triglycerides
Percentage change in triglycerides
Measured: Baseline (day 0) to end of each condition (day 21)
Apolipoprotein B
percentage change in Apolipoprotein B
Measured: Baseline (day 0) to end of each condition (day 21)
Homeostasis model assessments of insulin resistance (HOMA-IR)
Percentage changes in HOMA-IR calculated from fasting glucose and insulin values
Measured: Baseline (day 0) to end of each condition (day 21)
Homeostasis model assessments of β-cell function (HOMA-B)
Percentage changes in HOMA-B calculated from fasting glucose and insulin values
Measured: Baseline (day 0) to end of each condition (day 21)
Matsuda insulin sensitivity index
Percentage change in Matsuda insulin sensitivity index determined from a liquid-meal tolerance test (LMTT)
Measured: Baseline (day 0) to end of each condition (day 21)
Disposition index
Percentage change in disposition index from the LMTT (a measure of pancreatic β-cell function)
Measured: Baseline (day 0) to end of each condition (day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start10 Apr 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- ACH Food Companies, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514663
- Sponsor's protocol ID
- MB-2546
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07514663
- Acronym / sponsor ID
- MB-2546
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- ACH Food Companies, Inc.
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn Oil | Experimental | Other: corn oilCorn oil (4 tablespoons/d) will be provided in 3 servings of study products per day (yogurt, dinner roll, and muffin). |
| Avocado Oil | Active comparator | Other: Avocado OilAvocado oil (4 tablespoons/d) will be provided in 3 servings of study products per day (yogurt, dinner roll, and muffin). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corn oilCorn oil will be provided in yogurt, rolls and muffins throughout the study period. | Other | Corn Oil |
| Avocado OilAvocado oil will be provided in yogurt, rolls and muffins throughout the study period. | Other | Avocado Oil |
Primary outcome
Non-high density lipoprotein cholesterol (non-HDL-C)
Time frame: Baseline (day 0) to end of each condition (day 21)
Percentage change in non-HDL-C concentration
9 secondary outcomes
Total Cholesterol
Time frame: Baseline (day 0) to end of each condition (day 21)
Low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline (day 0) to end of each condition (day 21)
High-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline (day 0) to end of each condition (day 21)
Triglycerides
Time frame: Baseline (day 0) to end of each condition (day 21)
Apolipoprotein B
Time frame: Baseline (day 0) to end of each condition (day 21)
Homeostasis model assessments of insulin resistance (HOMA-IR)
Time frame: Baseline (day 0) to end of each condition (day 21)
Homeostasis model assessments of β-cell function (HOMA-B)
Time frame: Baseline (day 0) to end of each condition (day 21)
Matsuda insulin sensitivity index
Time frame: Baseline (day 0) to end of each condition (day 21)
Disposition index
Time frame: Baseline (day 0) to end of each condition (day 21)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corn oil and Avocado Oil in people with Hypercholesterolemia, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caryn Adams, MPH (630-469-6600, cwolfe@mbclinicalresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-high density lipoprotein cholesterol (non-HDL-C) (time frame: Baseline (day 0) to end of each condition (day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.