Clinical trial NCT03063320: The Effect of Spice Consumption on Postprandial Vascular Function
Official title: The Effect of Chronic Consumption of Popular Spices on Postprandial Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 43
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3 period randomized cross over
Primary purpose: PREVENTION

Brief summary: A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.

Detailed description: A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.

Eligibility criteria: Inclusion Criteria:

Men and postmenopausal women Overweight or obese (25-35kg/m2) Non-smoking 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 flow mediated dilation
timeFrame: Change from baseline at 2 hours and 4 hours after meal consumption
Secondary outcomes:
measure: Lipid and lipoproteins
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Plasma Inflammatory cytokines
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Inflammatory cytokines in isolated peripheral blood mononuclear cells
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Glucose
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Insulin
timeFrame: Change from baseline during the 4 hours after meal consumption
measure: Plasma antioxidants
timeFrame: Change from baseline during the 4 hours after meal consumption
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References: