A Controlled-Feeding Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Cashews followed by Control
* Other: Control followed by Cashews


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI of ≥18.00 and ≤32.00 kg/m^2 Fasting LDL-C level ≥130 mg/dL and <200 mg/dL Fasting TG ≤350 mg/dL Exclusion Criteria: CHD or CHD risk equivalent Pregnancy Use of lipid altering medications which cannot be stopped Certain liver, kidney, lung, or gastrointestinal conditions Poorly controlled hypertension Certain medications Allergy or sensitivity to nuts or other food/beverage or food/beverage component Active cancers treated within prior 2 years (except non-melanoma skin cancer) Significant weight loss or gain within prior 3 months

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Crossover 1: Control Diet followed by Active Diet<br>Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts | Other: Control followed by Cashews<br>* 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.<br>|
| Other: Crossover 2: Active Diet followed by Control Diet<br>Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts | Other: Cashews followed by Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cashew, Lipoprotein