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

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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

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE May 12, 2016
Last Update Posted Date November 1, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Controlled-Feeding Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
Official Title  ICMJE A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Crossover 1: Control Diet followed by Active Diet
    Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts
    Intervention: Other: Control followed by Cashews
  • Crossover 2: Active Diet followed by Control Diet
    Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts
    Intervention: Other: Cashews followed by Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02769741
Other Study ID Numbers  ICMJE BIO-1509
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kraft Heinz Company
Study Sponsor  ICMJE Kraft Heinz Company
Collaborators  ICMJE BioFortis
Investigators  ICMJE
Principal Investigator: Andrea Lawless, MD BioFortis
PRS Account Kraft Heinz Company
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP