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Completed

NCT Number: NCT02628171

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

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.

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Key information

Conditions

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Base Diet

Other

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.

Base Diet with Cashew Nuts

Other

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2015
Registry last updated
May 12, 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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