The Effect of Spice Consumption on Postprandial Vascular Function

Cardiovascular Risk Factor Clinical Trial

Official title:

The Effect of Chronic Consumption of Popular Spices on Postprandial Vascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063320
• Other study ID #: PKE Spice PP
• Status: Completed
• Phase: N/A
• Start date: January 25, 2017
• Est. completion date: February 26, 2020

Study information

• Verified date: September 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Other:
• Spice blend
Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in flow mediated dilation	Endothelial function measured by FMD	Change from baseline at 2 hours and 4 hours after meal consumption
Secondary	Lipid and lipoproteins	Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides	Change from baseline during the 4 hours after meal consumption
Secondary	Plasma Inflammatory cytokines	Serum: IL-1ß, 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 during the 4 hours after meal consumption
Secondary	Inflammatory cytokines in isolated peripheral blood mononuclear cells	TNF-alpha, IL-6,NF-?B, I-?B, MAP kinase, COX-2, iNOS from stimulated and unstimulated lipopolysaccharides in peripheral blood mononuclear cells. Activation status of macrophages.	Change from baseline during the 4 hours after meal consumption
Secondary	Glucose	Plasma glucose	Change from baseline during the 4 hours after meal consumption
Secondary	Insulin	Plasma insulin	Change from baseline during the 4 hours after meal consumption
Secondary	Plasma antioxidants	hydrophilic ORAC, lipophilic ORAC, total ORAC	Change from baseline during the 4 hours after meal consumption