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

K

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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