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The Effect of Spice Consumption on Postprandial Vascular Function

Sponsor
Penn State University (Other)
Overall Status
Completed
CT.gov ID
NCT03063320
Collaborator
(none)
13
Enrollment
1
Location
3
Arms
23.2
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Spice blend
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
3 period randomized cross over3 period randomized cross over
Masking:
Single (Outcomes Assessor)
Masking Description:
Person assessing the outcome measures will be blinded to participant allocation
Primary Purpose:
Prevention
Official Title:
The Effect of Chronic Consumption of Popular Spices on Postprandial Vascular Function
Actual Study Start Date :
Jan 25, 2017
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in flow mediated dilation [Change from baseline at 2 hours and 4 hours after meal consumption]

    Endothelial function measured by FMD

Secondary Outcome Measures

  1. Lipid and lipoproteins [Change from baseline during the 4 hours after meal consumption]

    Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides

  2. Plasma Inflammatory cytokines [Change 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

  3. Inflammatory cytokines in isolated peripheral blood mononuclear cells [Change 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.

  4. Glucose [Change from baseline during the 4 hours after meal consumption]

    Plasma glucose

  5. Insulin [Change from baseline during the 4 hours after meal consumption]

    Plasma insulin

  6. Plasma antioxidants [Change from baseline during the 4 hours after meal consumption]

    hydrophilic ORAC, lipophilic ORAC, total ORAC

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn State University University Park Pennsylvania United States 16802

Sponsors and Collaborators

  • Penn State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier:
NCT03063320
Other Study ID Numbers:
  • PKE Spice PP
First Posted:
Feb 24, 2017
Last Update Posted:
Mar 22, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 22, 2019