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Official title Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile
ClinicalTrials.gov ID: NCT07514663
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74. Healthy volunteers may be eligible.
You may be able to join 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.
You likely can't join 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...
- Atherosclerotic cardiovascular disease, including any of the following: clinical signs of atherosclerosis including peripheral arterial disease...
- History or presence of a clinically significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary...
See the full eligibility criteria
Who can 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.
- 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...
What rules you out
- 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...
- 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...
- History or presence of a clinically significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary, pancreatic, neurologic, psychiatric, inflammatory or biliary disorder that...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Addison, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Addison, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.