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| Name | Class |
|---|---|
| Hass Avocado Board | OTHER |
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The objective of this trial is to assess the effects of replacing foods high in refined carbohydrates, particularly added sugars, with avocado (isocaloric substitution) on biomarkers of inflammation and insulin sensitivity in adults with elevated hs-CRP and central adiposity. Eligible participants will complete two 4-week interventions (1 avocado/d and control) separated by a 2-week washout phase. Participants will complete a total of 7 clinic visits including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 4-week diet condition (visit 3 & 6 on day 21 and visits 4 & 7 on day 28), and one visit at the conclusion of the washout phase/start of the second condition (visit 5, day 0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avocado Group | Experimental | 1 avocado/day provided by 3 servings study products per day (muffins and pudding) |
|
| Control Group | Other | 3 study products per day will be provided with energy from avocado will be replaced with refined carbohydrate, especially added sugars |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avocado | Other | Active foods will provide the equivalent of one medium to large avocado/day in foods such as muffins and pudding, where avocado replaces refined carbohydrate, especially added sugars |
| Measure | Description | Time Frame |
|---|---|---|
| Composite measure of inflammatory biomarkers | Change from baseline for a composite measure of inflammatory biomarkers including high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), interleukin-10 (IL-10), and tumor Necrosis Factor-alpha (TNF-α). | Change from baseline (day 0) to end of each condition (day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Homeostasis model assessments of insulin resistance (HOMA-IR) | Changes in (HOMA-IR) | Change from baseline (day 0) to end of each condition (day 28) |
| Homeostasis model assessments of β-cell function (HOMA-B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Campbell | Contact | 630-469-6600 | scampbell@mbclinicalresearch.com | |
| Caryn Adams | Contact | 630-469-6600 | cwolfe@mbclinicalresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois Institute of Technology | Chicago | Illinois | 60616 | United States |
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| Control | Other | Control foods will have similar energy contents to active foods, but energy from avocado will be replaced with refined carbohydrate, especially added sugars. |
|
Changes in HOMA-B
| Change from baseline (day 0) to end of each condition (day 28) |
| Matsuda index of insulin sensitivity | Change in Matsuda index of insulin sensitivity | Change from baseline (day 0) to end of each condition (day 28) |
| Disposition index | Change in disposition index | Change from baseline (day 0) to end of each condition (day 28) |
| high sensitivity C-reactive protein (hs-CRP) | Change in hs-CRP | Change from baseline (day 0) to end of each condition (day 28) |
| Interleukin-6 (IL-6) | Change in IL-6 | Change from baseline (day 0) to end of each condition (day 28) |
| Interleukin-1 beta (IL-1β) | Change in IL-1β | Change from baseline (day 0) to end of each condition (day 28) |
| Interleukin-10 (IL-10) | Change in IL-10 | Change from baseline (day 0) to end of each condition (day 28) |
| Tumor Necrosis Factor-alpha (TNF-α) | Change in TNF-α | Change from baseline (day 0) to end of each condition (day 28) |
| Fibrinogen | Change in fibrinogen | Change from baseline (day 0) to end of each condition (day 28) |
| Soluble Intercellular Adhesion Molecule-1 (sICAM-1) | Change in sICAM-1 | Change from baseline (day 0) to end of each condition (day 28) |
| Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) | Change in sVCAM-1 | Change from baseline (day 0) to end of each condition (day 28) |
| Total Cholesterol | Change in total cholesterol | Change from baseline (day 0) to end of each condition (day 28) |
| Low-density lipoprotein cholesterol (LDL-C) | Change in LDL-C | Change from baseline (day 0) to end of each condition (day 28) |
| High-density lipoprotein cholesterol (HDL-C) | Change in HDL-C | Change from baseline (day 0) to end of each condition (day 28) |
| Non-high-density lipoprotein cholesterol (non-HDL-C) | Change in non-HDL-C | Change from baseline (day 0) to end of each condition (day 28) |
| Triglycerides | Change in triglycerides | Change from baseline (day 0) to end of each condition (day 28) |
| Apolipoprotein B (ApoB) | Change in ApoB | Change from baseline (day 0) to end of each condition (day 28) |
| Systolic and diastolic blood pressures. | Change in resting, seated systolic and diastolic blood pressures. | Change from baseline (day 0) to end of each condition (day 28) |
| University of Nevada, Las Vegas | Las Vegas | Nevada | 89154 | United States |
|
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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