This study is a randomized 3-period crossover, controlled feeding study designed to evaluate the effects of the most commonly consumed spices in the U.S. on CVD risk factors, inflammation \& immune function, and diet satisfaction in participants at risk for CVD.
A 3-period randomized crossover controlled-feeding study will be conducted. Participants will be randomly assigned to receive each 4-week treatment (diet) in random order. Each test diet period will be separated by a standard 4-week compliance break. Data collection will be conducted across at baseline (start of study) and the end of each diet period to assess the effects of chronic spice consumption on selected cardiovascular endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
71
Average American diet with different levels of spices
Penn State University
University Park, Pennsylvania, United States
Change in lipid/lipoprotein profile
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Time frame: Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Central blood pressure
Time frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Brachial blood pressure
Time frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Augmentation index
Time frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Pulse wave velocity
Time frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
HDL function
Time frame: Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Change in Glucose
Time frame: Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Change in Insulin
Time frame: Change from baseline in insulin at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Diet satisfaction
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Questionnaire
Time frame: After each 4 week diet period
Change in flow mediated dilation
Only to be completed on men and postmenopausal women
Time frame: Change from baseline in flow mediated dilation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Inflammation and immune fuction
Serum: IL-1β, IL-6, IL-10, IL-12p70, interferon-gamma, monocyte chemoattractant protein-1, macrophage inflammatory protein-1alpha, TNF-alpha, vascular endothelial growth factor
Time frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Ambulatory blood pressure
Time frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
in vitro production of inflammatory cytokines and immune markers
effect of spice on in vitro production of TNF-alpha, IL-6,NF-κB, I-κB, MAP kinase, COX-2, iNOS from stimulated and unstimulated lipopolysaccharides in peripheral blood mononuclear cells. Activation status of macrophages.
Time frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Change in lipoprotein particle size and subclasses
LDL, LDLR \[i.e., LDL-(IDL + Lp(a))\], Lp(a), IDL, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non HDL, Remnant Lipoproteins, LDL4, LDL3, LDL2, ApoB100, ApoA1, ApoB100:A1.
Time frame: Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)