The purpose of this research is to build the evidence base for approval of FDA health claims related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled feeding study was designed to compare the effects of two blood cholesterol lowering diets that meet the American Heart Association recommendations. The nutrient profiles of the control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25 men and women with moderately elevated LDL-C. The investigators hypothesize that a cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response, effect on LDL particle size, abdominal adiposity and vascular health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
61
1.5 oz almonds/day
Penn State University
University Park, Pennsylvania, United States
Lipid/lipoprotein profile
Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides are measured as part of the lipoprotein profile. Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Lipoprotein (LDL, HDL, VLDL, IDL) subclasses
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Abdominal adiposity as measured by dual-energy x-ray absorptiometry
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Leg adiposity as measured by dual-energy x-ray absorptiometry
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Apolipoproteins (A1 and B)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Vascular health (plasma nitric oxide)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Total body composition as measured by dual-energy x-ray absorptiometry
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Waist circumference
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
HDL functionality (cholesterol efflux)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Cholesterol absorption/synthesis (measured by plasma plant sterols and cholesterol precursors)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
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