Cardiovascular Disease, Inflammation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERControlled feeding diet
Average American diet with different levels of spices
Sponsors
McCormick Science Institute
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* overweight or obese (25-35kg/m2) * non-smoking * male or female * waist circumference \>= 94cm for men and \>=80cm for women * at least one other of the following: LDL- cholesterol \>130mg/dL; CRP \>1mg/L; triglycerides \>=150mg/dL; HDL \<40mg/dL for men or \<50mg/dL for women; systolic blood pressure \>= 130mmHg or diastolic \>= 85mmHg; fasting glucose \>=100mg/dL
Exclusion criteria
* diabetes (fasting glucose \>126mg/dL) * hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg) * prescribed anti-hypertensive or glucose lowering drugs * established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease * use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals * pregnancy or lactation * weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study * vegetarianism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lipid/lipoprotein profile | 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) | Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glucose | Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | — |
| Ambulatory blood pressure | 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 | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 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. |
| Change in lipoprotein particle size and subclasses | Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 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. |
| Central blood pressure | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | — |
| Brachial blood pressure | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | — |
| Augmentation index | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | — |
| Pulse wave velocity | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | — |
| HDL function | 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 Insulin | 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 | After each 4 week diet period | Questionnaire |
| Change in flow mediated dilation | 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) | Only to be completed on men and postmenopausal women |
| Inflammation and immune fuction | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary isoprostanes | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | — |
| Change in composition of the gut microbiome | Change from baseline in composition of the gut microbiome at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | PCR quantification of total 16S rRNA |
| Change in LDL oxidation | Change from baseline in LDL oxidation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | — |
Countries
United States
Outcome results
None listed