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| Name | Class |
|---|---|
| BioFortis | OTHER |
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This study will assess the nutritional effect of cashews on LDL-C concentrations and secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and women with moderately elevated cholesterol.
This trial will utilize a randomized, two-period crossover design to examine the effects of cashew consumption on LDL-C and other aspects of the fasting lipoprotein lipid profile in healthy, moderately hyper-cholesterolemic individuals consuming a typical "American diet." Two arms consisting of two 28-day controlled-feeding treatment periods will allow for an isocaloric comparison of a diet with or without cashews.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover 1: Control Diet followed by Active Diet | Other | Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts |
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| Crossover 2: Active Diet followed by Control Diet | Other | Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cashews followed by Control | Other | Participants will receive the active diet with cashew nuts as a daily snack during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the control diet at the same calorie level, but with a control snack instead of cashew nuts during Test Period II. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C concentration measured in blood | % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II. |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol change | % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II. | |
| HDL-cholesterol change | % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Lawless, MD | BioFortis | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28356271 | Derived | Mah E, Schulz JA, Kaden VN, Lawless AL, Rotor J, Mantilla LB, Liska DJ. Cashew consumption reduces total and LDL cholesterol: a randomized, crossover, controlled-feeding trial. Am J Clin Nutr. 2017 May;105(5):1070-1078. doi: 10.3945/ajcn.116.150037. Epub 2017 Mar 29. |
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| Control followed by Cashews | Other | Participants will receive a controlled diet without cashew nuts during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the active diet at the same calorie level, but with cashew nuts as a daily snack during Test Period II. |
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| Non-HDL-cholesterol change | % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II. |
| Triglyceride change | % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II. |
| Total cholesterol/HDL-cholesterol ratio change | % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II. |