An interventional study of Cashews followed by Control and Control followed by Cashews in Healthy Volunteers, sponsored by Kraft Heinz Company. Completed. Open to participants aged 21 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-01.
Sponsored by Kraft Heinz Company · Not applicable, Interventional, and Prevention
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.
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.
This is the only study on the registry with Kraft Heinz Company as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts
Other: Control followed by Cashews
Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts
Other: Cashews 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.
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.
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.
Total cholesterol change
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
HDL-cholesterol change
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Non-HDL-cholesterol change
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
Triglyceride change
Time frame: % 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
Time frame: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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