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| Name | Class |
|---|---|
| Hass Avocado Board | OTHER |
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The objective of this study is to assess the effects of replacing energy from SoFAS with energy from avocado on non-high-density lipoprotein cholesterol (non-HDL-C) and other aspects of the cardiometabolic health profile including fasting lipoprotein lipid and particle concentrations, insulin sensitivity and blood pressure in men and women with elevated triglycerides (TG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Average American Diet With SoFAS Replaced With Avocado | Experimental | Average American diet with foods that provide the equivalent of 1 medium to large avocado per day. It is anticipated that energy from avocado would replace 12-15% of daily energy, roughly half from solid fats and half from added sugars (SoFAS). |
|
| Average American Diet | Placebo Comparator | Average American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Average American Diet With SoFAS Replaced With Avocado | Other | Replacing energy from solid fats and added sugars (SoFAS) with Avocado as part of an average American diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-HDL-C | Percent change from baseline to the end of each treatment condition in non-HDL-C | Up to 21 days for each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol (Total-C) | Change or percent change from baseline to the end of each treatment condition | Up 21 days for each treatment period |
| High-density lipoprotein cholesterol (HDL-C) | Change or percent change from baseline to the end of each treatment condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States | ||
| I-CTSI Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41397527 | Derived | Gletsu-Miller N, Wilcox ML, Spence LA, Wright AJ, Guarneiri LL, Nadeem MM, Hutter MJ, Sprague KL, Brown AW, Friedman AN, Kirkpatrick CF, Maki KC. Effects of replacing solid fats and added sugars with avocado in adults with elevated cardiometabolic risk: a randomized, double-blind, controlled feeding, crossover trial. Am J Clin Nutr. 2026 Feb;123(2):101137. doi: 10.1016/j.ajcnut.2025.101137. Epub 2025 Dec 13. |
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| Average American Diet | Other | Average American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey. |
|
| Up to 21 days for each treatment period |
| Low-density lipoprotein cholesterol (HDL-C) | Change or percent change from baseline to the end of each treatment condition | Up to 21 days for each treatment period |
| Triglyceride (TG) | Change or percent change from baseline to the end of each treatment condition | Up to 21 days for each treatment period |
| Total-C/HDL-C Ration | Change or percent change from baseline to the end of each treatment condition | Up to 21 days for each treatment period |
| Lipoprotein particle and subclass concentrations | Change or percent change from baseline to the end of each treatment condition | Up to 21 days for each treatment period |
| Matsuda insulin sensitivity index | Change or percent change from baseline to the end of each treatment condition | Up to 21 days for each treatment period |
| Disposition index from the liquid meal tolerance test [LMTT] (a measure of pancreatic beta-cell function) | Change or percent change from baseline to the end of each treatment condition | Measured at baseline and end of each treatment period |
| Homeostasis model assessments of insulin sensitivity (HOMA2-%S), insulin resistance (HOMA-IR, linear model) and beta-cell function (HOMA2-%B) | Change or percent change from baseline to the end of each treatment condition | Up to 21 days for each treatment period |
| Seated, resting systolic and diastolic blood pressures and heart rate | Change or percent change from baseline to the end of each treatment condition | Up to 21 days for each treatment period |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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