A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kraft Heinz Company
- Enrollment
- 51
- Primary Endpoint
- Change in LDL-C concentration measured in blood
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Crossover 1: Control Diet followed by Active Diet
Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts
Intervention: Control followed by Cashews (Other)
Crossover 2: Active Diet followed by Control Diet
Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts
Intervention: Cashews followed by Control (Other)
Outcomes
Primary Outcomes
Change in LDL-C concentration measured in blood
Time Frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Secondary Outcomes
- 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.)