ClinicalTrials.gg
RecruitingNCT07514663Updated Apr 17, 2026

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

An interventional study of corn oil and Avocado Oil in Hypercholesterolemia, sponsored by Midwest Center for Metabolic and Cardiovascular Research. Recruiting at 1 site in United States. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Midwest Center for Metabolic and Cardiovascular Research · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 379 studies in Hypercholesterolemia with a site in United States — 32 open to participants now, 42 under way, 11 of them phase 3. Hypercholesterolemia · United States.

Planned enrollment
249th of 347
54 · median 120
Started
2026
with 12 others
No phase
101 of 379
14 open now
Primary completion
2026-09
later than 5 of 40 live
Registered
370th of 379
by date

Among the 379 studies in Hypercholesterolemia with a site in United States, this one is the 249th largest by planned enrollment of the 347 interventional ones, is one of 13 that started in 2026, is one of 101 with no phase, reaches primary completion later than 5 of the 40 other live ones, and was the 370th registered.

By phase

379 studies; the count open now beside each. This study's row is marked.

Phase 3102 · 6 open
No phasethis study101 · 14 open
Phase 266 · 5 open
Phase 140 · 2 open
Phase 433 · 1 open
Observational31 · 4 open
Phase 2/34 · 0 open
Phase 1/22 · 0 open

By the year they started

First in 1976; this study’s year is marked. 13 started in 2026.

Size and results

Median enrollment 120 across the 347 interventional studies, 260 across the 31 observational. Of the 319 that completed or were terminated, 161 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 379 studies in Hypercholesterolemia with a site in United States, or all of them as a file.
02

Study 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).

03

Conditions studied

  • Hypercholesterolemia
04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female 18 - 74 years of age, inclusive.
  2. ≥18.5 and \<35.0 kg/m2.
  3. Fasting non-HDL-C level ≥125 mg/dL and \<225 mg/dL.
  4. Fasting TG level \<500 mg/dL.
  5. Vein access scale score of 7-10.
  6. Judged by the Investigator to be in generally good health, based on medical history and screening measurements.
  7. Calculated energy needs of ≥1800 kcal/d per the Mifflin-St Jeor Equation, with an adjustment for energy expended in physical activity.
  8. Willing to consume only study-related foods/beverages during each 21-d condition and visit the clinic each weekday morning during this time.
  9. If a smoker, subject has no plans to change smoking habits during the study period.
  10. 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 to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion criteria

Exclusion Criteria:

  1. Known allergy or sensitivity to study product or any ingredients of the study product or assigned meals/snacks/beverages provided.
  2. Abnormal laboratory test results of clinical significance. One retest may be allowed on a case-by-case basis at the discretion of the Investigator.
  3. Fasting blood glucose ≥126 mg/dL at screening or known type 1 or type 2 diabetes mellitus.
  4. 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).
  5. 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, or stroke of carotid origin] or >50% stenosis on angiography or ultrasound) or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
  6. History or presence of a 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.
  7. History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
  8. Unstable use (defined as initiation or change in dosage) of anti-hypertensive medication within 12 weeks of visit 1 (day -7).
  9. Use of beta-adrenergic blockers and/or high-dose (>25 mg/d) thiazide diuretics within 4 weeks of visit 1 (day -7).
  10. Unstable use (defined as initiation or change in dose) of any thyroid hormone replacement within 12 weeks of visit 1 (day -7).
  11. Unstable use (defined as initiation or change in dosage, agent, or regimen) of statin medication within 12 weeks of visit 1 (day -7).
  12. 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).
  13. 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.
  14. 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).
  15. 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).
  16. Use of systemic within 4 weeks of visit 1 (day -7).
  17. Use of prescribed weight-loss drugs or programs within 12 weeks prior to visit 1 (day -7).
  18. Use of over-the-counter weight-loss medications, dietary supplements, or programs within 2 weeks prior to visit 2 (day 0).
  19. Weight loss or gain >4.5 kg in the 3 months prior to visit 1 (day -7).
  20. Extreme dietary habits (e.g., very-low-carbohydrate, vegetarian, vegan diets) in the opinion of the Investigator.
  21. History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
  22. 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.
  23. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of and is unwilling to commit to the use of a medically approved form of throughout the study period. The method of contraception must be recorded in the source document.
  24. Positive urine drug screen for illicit drugs at visit 1.
  25. 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).
  26. Exposure to any non-registered drug product within 30 d prior to visit 1 (day -7).
  27. Any condition the Investigator believes would interfere with his or her ability to provide , comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Corn Oil

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

    Other: corn oil

  • Active comparator
    Avocado Oil

    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

  • Othercorn oil

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

  • OtherAvocado Oil

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

06

What researchers measure

Primary outcomes

  1. Non-high density lipoprotein cholesterol (non-HDL-C)

    Percentage change in non-HDL-C concentration

    Time frame: Baseline (day 0) to end of each condition (day 21)

Secondary outcomes

  1. Total Cholesterol

    Percentage change in total cholesterol

    Time frame: Baseline (day 0) to end of each condition (day 21)

  2. Low-density lipoprotein cholesterol (LDL-C)

    Percentage change in low-density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline (day 0) to end of each condition (day 21)

  3. High-density lipoprotein cholesterol (HDL-C)

    Percentage change in high-density lipoprotein cholesterol (HDL-C)

    Time frame: Baseline (day 0) to end of each condition (day 21)

  4. Triglycerides

    Percentage change in triglycerides

    Time frame: Baseline (day 0) to end of each condition (day 21)

  5. Apolipoprotein B

    percentage change in Apolipoprotein B

    Time frame: Baseline (day 0) to end of each condition (day 21)

  6. Homeostasis model assessments of insulin resistance (HOMA-IR)

    Percentage changes in HOMA-IR calculated from fasting glucose and insulin values

    Time frame: Baseline (day 0) to end of each condition (day 21)

  7. Homeostasis model assessments of β-cell function (HOMA-B)

    Percentage changes in HOMA-B calculated from fasting glucose and insulin values

    Time frame: Baseline (day 0) to end of each condition (day 21)

  8. Matsuda insulin sensitivity index

    Percentage change in Matsuda insulin sensitivity index determined from a liquid-meal tolerance test (LMTT)

    Time frame: Baseline (day 0) to end of each condition (day 21)

  9. Disposition index

    Percentage change in disposition index from the LMTT (a measure of pancreatic β-cell function)

    Time frame: Baseline (day 0) to end of each condition (day 21)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Sep 2026, 5 months after the start.

Of 133 non-industry interventional studies with no phase under Hypercholesterolemia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 5 months is below that.

Counting every sponsor, half of 151 studies reached it within 15 months; a quarter within 6 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2026
First posted
Apr 7, 2026
StartActual
Apr 10, 2026
Primary completionEst.
Sep 2026
CompletionEst.
Sep 2026
Last update
Apr 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07514663
Lead sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
ACH Food Companies, Inc.
Responsible party
Sponsor
First posted
Apr 7, 2026
Start date
Apr 10, 2026
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Apr 17, 2026

Study contacts

Caryn Adams, MPH
Contact
cwolfe@mbclinicalresearch.com
630-469-6600
Sara Campbell, MPH
Contact
scampbell@mbclinicalresearch.ocm
630-469-6600

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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