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

NCT ID: NCT02628171

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of cashew nuts (control).

Group Type: OTHER

Base Diet

Intervention Type: 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.

Cashew

Participants will receive a controlled diet, typical of an American diet, with 42 g/day of cashew nuts (base diet with cashew nuts).

Group Type: ACTIVE_COMPARATOR

Base Diet with Cashew Nuts

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

David Baer

Research Physiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

References

Baer DJ, Novotny JA. Consumption of cashew nuts does not influence blood lipids or other markers of cardiovascular disease in humans: a randomized controlled trial. Am J Clin Nutr. 2019 Feb 1;109(2):269-275. doi: 10.1093/ajcn/nqy242.

Reference Type: DERIVED

PMID: 30753323 (View on PubMed)

Other Identifiers

HS52

Identifier Type: -

Identifier Source: org_study_id