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Completed

NCT Number: NCT02769741

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cashews followed by Control

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.

Control followed by Cashews

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kraft Heinz Company

Industry

Collaborators

  • BioFortis

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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