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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02769741

Enrollment

Registered

2016-05-12

Start date

2016-01-31

Completion date

2016-06-30

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Cashew, Lipoprotein

Brief summary

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.

Detailed description

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.

Interventions

OTHERCashews followed by Control

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.

OTHERControl followed by Cashews

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in LDL-C concentration measured in blood	% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

Secondary

Measure	Time frame
Total cholesterol change	% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
HDL-cholesterol change	% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Non-HDL-cholesterol change	% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Triglyceride change	% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Total cholesterol/HDL-cholesterol ratio change	% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026