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| Name | Class |
|---|---|
| ACH Food Companies, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corn Oil | Experimental | Corn oil (4 tablespoons/d) will be provided in 3 servings of study products per day (yogurt, dinner roll, and muffin). |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corn oil | Other | Corn oil will be provided in yogurt, rolls and muffins throughout the study period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | Percentage change in total cholesterol | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caryn Adams, MPH | Contact | 630-469-6600 | cwolfe@mbclinicalresearch.com | |
| Sara Campbell, MPH | Contact | 630-469-6600 | scampbell@mbclinicalresearch.ocm |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Clinical Research | Recruiting | Addison | Illinois | 60101 | United States |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Avocado Oil | Other | Avocado oil will be provided in yogurt, rolls and muffins throughout the study period. |
|
| 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) | Baseline (day 0) to end of each condition (day 21) |
| Triglycerides | Percentage change in triglycerides | Baseline (day 0) to end of each condition (day 21) |
| Apolipoprotein B | percentage change in Apolipoprotein B | 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 | 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 | 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) | 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) | Baseline (day 0) to end of each condition (day 21) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |