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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Control followed by Cashews; Other: Cashews followed by Control

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Kraft Heinz Company
• Collaborators: BioFortis
• Investigators: Principal Investigator: Andrea Lawless, MD, Biofortis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Lipoprotein; Cashew
• Other Study ID Numbers: BIO-1509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED