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The Effect of Spice Consumption on Postprandial Vascular Function

Not Applicable
Completed
Conditions
Cardiovascular Risk Factor
Interventions
Other: Spice blend
Registration Number
NCT03063320
Lead Sponsor
Penn State University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
43
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Culinary SpiceSpice blendThe test meal (\~1200kcal and 44g fat) will contain \~7.4g of spice blend
Moderate SpiceSpice blendThe test meal (\~1200kcal and 44g fat) will contain \~3.7g of spice blend
Low SpiceSpice blendThe test meal (\~1200kcal and 44g fat) will contain \~0.6g of spice blend
Primary Outcome Measures
NameTimeMethod
Change in flow mediated dilationChange from baseline at 2 hours and 4 hours after meal consumption

Endothelial function measured by FMD

Secondary Outcome Measures
NameTimeMethod
GlucoseChange from baseline during the 4 hours after meal consumption

Plasma glucose

Plasma antioxidantsChange from baseline during the 4 hours after meal consumption

hydrophilic ORAC, lipophilic ORAC, total ORAC

InsulinChange from baseline during the 4 hours after meal consumption

Plasma insulin

Inflammatory cytokines in isolated peripheral blood mononuclear cellsChange from baseline during the 4 hours after meal consumption

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.

Lipid and lipoproteinsChange from baseline during the 4 hours after meal consumption

Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides

Plasma Inflammatory cytokinesChange from baseline during the 4 hours after meal consumption

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

Trial Locations

Locations (1)

Penn State University

🇺🇸

University Park, Pennsylvania, United States

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