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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769741
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
BioFortis
Information provided by (Responsible Party):
Kraft Heinz Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Cashews followed by Control Other: Control followed by Cashews Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. Triglyceride change [ Time Frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II. ]
  5. 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769741


Sponsors and Collaborators
Kraft Heinz Company
BioFortis
Investigators
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Principal Investigator: Andrea Lawless, MD BioFortis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kraft Heinz Company
ClinicalTrials.gov Identifier: NCT02769741    
Other Study ID Numbers: BIO-1509
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kraft Heinz Company:
Cashew
Lipoprotein