Corn and Avocado Oils for High Cholesterol

Overseen By Sara Campbell, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Midwest Center for Metabolic and Cardiovascular Research

Must not be taking: Beta blockers, Thiazide diuretics, Statins, others

Disqualifiers: Diabetes, Hypertension, Cardiovascular disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

I am willing to eat only study foods and visit the clinic every weekday for 21 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Participants undergo baseline assessments before starting the diet conditions

1 day

1 visit (in-person)

Diet Condition 1

Participants consume a controlled feeding diet with corn oil for 21 days

3 weeks

2 visits (in-person)

Washout

Participants return to their regular diet for a 21-day washout period

3 weeks

1 visit (in-person)

Diet Condition 2

Participants consume a controlled feeding diet with avocado oil for 21 days

3 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diet conditions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Avocado Oil
• Corn Oil

How Is the Trial Designed?

Group I: Corn Oil Experimental Treatment 1 Intervention

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

Group II: Avocado Oil Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Midwest Center for Metabolic and Cardiovascular Research

Lead Sponsor

Trials

22

Recruited

880+

ACH Food Companies, Inc.

Industry Sponsor

Trials

2

Recruited

80+