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| Name | Class |
|---|---|
| McCormick Science Institute | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SD-Low | Active Comparator | Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a minimal amount of spices (<1g/day for all diets). Post prandial test meal will be contain minimal amounts of spice. |
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| SD-Mod | Experimental | Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a moderate amount of spices (~3g/day in the 2100kcal diet). Post prandial test meal will be contain a moderate amount of spice. |
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| SD-Culinary | Experimental | Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a culinary dose of spices (6g/day in the 2100kcal diet). Post prandial test meal will be contain a culinary amount of spice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlled feeding diet | Other | Average American diet with different levels of spices |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in lipid/lipoprotein profile | Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Change in composition of the gut microbiome | PCR quantification of total 16S rRNA |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny Kris-Etherton, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36774112 | Derived | Petersen KS, Anderson S, Chen See JR, Leister J, Kris-Etherton PM, Lamendella R. Herbs and Spices Modulate Gut Bacterial Composition in Adults at Risk for CVD: Results of a Prespecified Exploratory Analysis from a Randomized, Crossover, Controlled-Feeding Study. J Nutr. 2022 Nov;152(11):2461-2470. doi: 10.1093/jn/nxac201. Epub 2022 Sep 2. | |
| 34601551 |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 Glucose | 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 | 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 | Questionnaire | After each 4 week diet period |
| Change in flow mediated dilation | Only to be completed on men and postmenopausal women | 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 | Change from baseline 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 | 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 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. | Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) |
| 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) |
| 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) |
| Oh ES, Petersen KS, Kris-Etherton PM, Rogers CJ. Four weeks of spice consumption lowers plasma proinflammatory cytokines and alters the function of monocytes in adults at risk of cardiometabolic disease: secondary outcome analysis in a 3-period, randomized, crossover, controlled feeding trial. Am J Clin Nutr. 2022 Jan 11;115(1):61-72. doi: 10.1093/ajcn/nqab331. |
| 34510174 | Derived | Petersen KS, Davis KM, Rogers CJ, Proctor DN, West SG, Kris-Etherton PM. Herbs and spices at a relatively high culinary dosage improves 24-hour ambulatory blood pressure in adults at risk of cardiometabolic diseases: a randomized, crossover, controlled-feeding study. Am J Clin Nutr. 2021 Dec 1;114(6):1936-1948. doi: 10.1093/ajcn/nqab291. |