The Effect of Spice Consumption on Postprandial Vascular Function

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Other: Spice blend

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Spice; The test meal (~1200kcal and 44g fat) will contain ~0.6g of spice blend	Other: Spice blend; Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon
Experimental: Moderate Spice; The test meal (~1200kcal and 44g fat) will contain ~3.7g of spice blend	Other: Spice blend; Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon
Experimental: Culinary Spice; The test meal (~1200kcal and 44g fat) will contain ~7.4g of spice blend	Other: Spice blend; Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in flow mediated dilation	Endothelial function measured by FMD	Change from baseline at 2 hours and 4 hours after meal consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid and lipoproteins	Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides	Change from baseline during the 4 hours after meal consumption
Plasma Inflammatory cytokines	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 during the 4 hours after meal consumption
Inflammatory cytokines in isolated peripheral blood mononuclear cells	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 during the 4 hours after meal consumption
Glucose	Plasma glucose	Change from baseline during the 4 hours after meal consumption
Insulin	Plasma insulin	Change from baseline during the 4 hours after meal consumption
Plasma antioxidants	hydrophilic ORAC, lipophilic ORAC, total ORAC	Change from baseline during the 4 hours after meal consumption

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PKE Spice PP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No