Clinical trial NCT02769741: A Controlled-Feeding Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
Official title: A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Cashew
Lipoprotein
Lead sponsor: Kraft Heinz Company
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2016-05-12
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in LDL-C concentration measured in blood
timeFrame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Secondary outcomes:
measure: Total cholesterol change
timeFrame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
measure: HDL-cholesterol change
timeFrame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
measure: Non-HDL-cholesterol change
timeFrame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
measure: Triglyceride change
timeFrame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
measure: Total cholesterol/HDL-cholesterol ratio change
timeFrame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Other outcomes:
Locations:
Study officials:
affiliation: BioFortis
name: Andrea Lawless, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mah E, Schulz JA, Kaden VN, Lawless AL, Rotor J, Mantilla LB, Liska DJ. Cashew consumption reduces total and LDL cholesterol: a randomized, crossover, controlled-feeding trial. Am J Clin Nutr. 2017 May;105(5):1070-1078. doi: 10.3945/ajcn.116.150037. Epub 2017 Mar 29.