Clinical trial NCT03064932: Effect of a Spice Blend on Cardiovascular Risk Factors and Diet Satisfaction
Official title: The Effect of Chronic Consumption of Popular Spices on Risk Factors for Cardiovascular Disease (CVD), Inflammation & Immune Function, and Diet Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Inflammation
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: McCormick Science Institute
First posted: 2017-02-27
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in lipid/lipoprotein profile
timeFrame: 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)
Secondary outcomes:
measure: Central blood pressure
timeFrame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: Brachial blood pressure
timeFrame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: Augmentation index
timeFrame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: Pulse wave velocity
timeFrame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: HDL function
timeFrame: 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: Change in Glucose
timeFrame: Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: Change in Insulin
timeFrame: Change from baseline in insulin at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: Diet satisfaction
timeFrame: After each 4 week diet period
measure: Change in flow mediated dilation
timeFrame: 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)
measure: Inflammation and immune fuction
timeFrame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: Ambulatory blood pressure
timeFrame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: in vitro production of inflammatory cytokines and immune markers
timeFrame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: Change in lipoprotein particle size and subclasses
timeFrame: Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Other outcomes:
measure: Change in LDL oxidation
timeFrame: Change from baseline in LDL oxidation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
measure: Change in composition of the gut microbiome
timeFrame: 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)
measure: Change in urinary isoprostanes
timeFrame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Cardiovascular Disease: Results of a Pre-Specified Exploratory Analysis from a Randomized, Crossover, Controlled-Feeding Study. J Nutr. 2022 Sep 2;152(11):2461-70. doi: 10.1093/jn/nxac201. Online ahead of print.
citation: 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.
citation: 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.