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

NCT02628171 | Completed

• 1 other identifier: HS52
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Change in lipid/lipoprotein profile will be measured in blood

  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

  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

  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 Outcomes (5)

• Pulse Wave will be measured using Sphygmocor EXCEL

  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

  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

  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

  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

  Week 0, end of diet period 1 (week 4), beginning of diet period 2 (week 6), end of diet period 2 (week 10)

Study Arms (2)

Control

OTHER

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

Other: Base Diet

Cashew

ACTIVE COMPARATOR

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

Interventions

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.

Control

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.

Cashew

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

• 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.

  PMID: 30753323 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: December 11, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)