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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769741
• Other study ID #: BIO-1509
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: October 28, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Kraft Heinz Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 79 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kraft Heinz Company	BioFortis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Total cholesterol change		% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.	No
Secondary	HDL-cholesterol change		% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.	No
Secondary	Non-HDL-cholesterol change		% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.	No
Secondary	Triglyceride change		% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.	No
Secondary	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.	No