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

NCT ID: NCT02769741

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Healthy Volunteers

Keywords

Cashew; Lipoprotein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Crossover 1: Control Diet followed by Active Diet

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

Group Type: OTHER

Control followed by Cashews

Intervention Type: OTHER

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.

Crossover 2: Active Diet followed by Control Diet

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

Group Type: OTHER

Cashews followed by Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

Kraft Heinz Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Lawless, MD

Role: PRINCIPAL_INVESTIGATOR

BioFortis

References

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.

Reference Type: DERIVED

PMID: 28356271 (View on PubMed)

Other Identifiers

BIO-1509

Identifier Type: -

Identifier Source: org_study_id