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

Kraft Heinz

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Cashews followed by Control; Other: Control followed by Cashews

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02769741

BIO-1509

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 21 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Crossover 1: Control Diet followed by Active Diet

Other group

Description:

Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts

Treatment:

Other: Control followed by Cashews

Crossover 2: Active Diet followed by Control Diet

Other group

Description:

Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts

Treatment:

Other: Cashews followed by Control