Overview

This trial has been completed.

Condition healthy volunteers
Treatments cashews followed by control, control followed by cashews
Sponsor Kraft Heinz Company
Collaborator BioFortis
Start date January 2016
End date June 2016
Trial size 51 participants
Trial identifier NCT02769741, BIO-1509

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(Other)
Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts
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)
Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts
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.

Primary Outcomes

Measure
Change in LDL-C concentration measured in blood
time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

Secondary Outcomes

Measure
Total cholesterol change
time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
HDL-cholesterol change
time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Non-HDL-cholesterol change
time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Triglyceride change
time frame: % 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
time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

Eligibility Criteria

Male or female participants from 21 years up to 79 years old.

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

Additional Information

Official title A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
Principal investigator Andrea Lawless, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Kraft Heinz Company.