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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Control followed by Cashews; Other: Cashews followed by Control

• Registration Number: NCT02769741
• Lead Sponsor: Kraft Heinz Company

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crossover 1: Control Diet followed by Active Diet	Control followed by Cashews	Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts
Crossover 2: Active Diet followed by Control Diet	Cashews followed by Control	Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.