Impact of Cashew Nuts in the Human Diet: Measured Energy Value and Effects on Cardiovascular Disease Risk Factors

May 10, 2016 updated by: David Baer, USDA Beltsville Human Nutrition Research Center
This study evaluates the effect of cashew nut consumption on traditional and emerging markers of cardiovascular disease (CVD) risk and determines the usable energy content of a serving of cashew nuts for accurate food labelling.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The cardioprotective effects of nuts have been well documented in the scientific literature; however, most of the research has been done with almonds, walnuts, and pistachios, while studies with cashew nuts are lacking. In addition to the cardiovascular literature, our recent studies measuring the metabolizable energy of nuts have demonstrated that the measured energy value of almonds, pistachios, and walnuts is lower than that predicted using the Atwater factors. However, the measured energy value of cashew nuts is unknown. There are two distinct aims of this study - determining the effects of cashew nut consumption on risk factors of CVD, and determining the energy value of cashew nuts in the human diet. The cardiovascular effects of cashew nuts will be determined by measuring both traditional and emerging risk factors. The metabolizable energy value of cashew nuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value than simply calculating energy value based on Atwater factors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • USDA Beltsville Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 20 and 38 kg/m2
  • Fasting glucose ≤ 126 mg/dL
  • Blood pressure ≤ 160/100 mm Hg

Exclusion Criteria:

  • Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
  • Use of cholesterol lowering medication
  • Use of medication to treat hypertension for less than 6 months
  • Active cardiovascular disease (such as a heart attack or procedure within the past six months or participation in a cardiac rehabilitation program within the last six months, stroke, or history/treatment for transient ischemic attacks in the past six months, or documented history of pulmonary embolus in the past six months)
  • Women who have given birth during the previous 12 months
  • Pregnant women or women who plan to become pregnant or become pregnant during the study
  • Lactating women
  • Type 2 diabetes
  • Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity
  • Smokers or other tobacco users (during 6 months prior to the start of the study)
  • History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
  • Known (self-reported) allergy or adverse reaction to cashew nuts or other nuts
  • Unable or unwilling to give informed consent or communicate with study staff
  • Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of cashew nuts (control).
Other: Base Diet
Participants will receive a controlled diet with 0 g/d of cashew nuts. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
Active Comparator: Cashew
Participants will receive a controlled diet, typical of an American diet, with 42 g/day of cashew nuts (base diet with cashew nuts).
Other: Base Diet with Cashew Nuts
Participants will receive a controlled diet with 42 g/d of cashew nuts. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in lipid/lipoprotein profile will be measured in blood
Time Frame: Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
The following will be measured in the blood on 2 consecutive days at the beginning and end of each 4-week diet period: lipids and lipoproteins, apolipoproteins, lipoprotein particle number/size, and proprotein convertase subtilisin/kexin type 9 (PCSK9).
Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
Metabolizable energy will be measured based on energy content of the consumed diet and excreta
Time Frame: Second week of diet period 1 (week 2)
The measured metabolizable energy value of cashew nuts will be calculated based on the energy content of the consumed diet and excreta.
Second week of diet period 1 (week 2)
Metabolizable energy will be measured based on energy content of the consumed diet and excreta
Time Frame: Second week of diet period 2 (week 8)
The measured metabolizable energy value of cashew nuts will be calculated based on the energy content of the consumed diet and excreta.
Second week of diet period 2 (week 8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulse Wave will be measured using Sphygmocor EXCEL
Time Frame: Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
Pulse wave analysis and pulse wave velocity will be conducted.
Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
Markers of vascular health will be measured in blood
Time Frame: Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
Adhesion molecules and endothelin-1 will be measured in the blood.
Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
Digestibility (%) will be calculated as (intake - excreted)/intake
Time Frame: Second week of diet period 1 (week 2), second week of diet period 2 (week 8)
Fat, protein, and fiber digestibility will be calculated (%) and the effect of cashew nuts on nutrient digestibility (%) will be assessed.
Second week of diet period 1 (week 2), second week of diet period 2 (week 8)
Change in systemic inflammation will be measured in blood
Time Frame: Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
Markers of systemic inflammation will be measured, such as IL-6, TNF-alpha, serum amyloid A, and CRP.
Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
Change in hemostasis will be measured in blood
Time Frame: Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)
Fibrinogen and factor VII will be measured in the blood.
Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USDA Beltsville Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS52

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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