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NCT Number: NCT03063320

The Effect of Spice Consumption 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.

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Key information

Conditions

Cardiovascular Risk Factor

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spice blend

Other

Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon

Primary outcomes

  1. Change in flow mediated dilation

    Time frame: Change from baseline at 2 hours and 4 hours after meal consumption

    Endothelial function measured by FMD

Secondary outcomes

  1. Lipid and lipoproteins

    Time frame: Change from baseline during the 4 hours after meal consumption

    Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides

  2. Plasma Inflammatory cytokines

    Time frame: 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

    Time frame: 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

    Time frame: Change from baseline during the 4 hours after meal consumption

    Plasma glucose

  5. Insulin

    Time frame: Change from baseline during the 4 hours after meal consumption

    Plasma insulin

  6. Plasma antioxidants

    Time frame: Change from baseline during the 4 hours after meal consumption

    hydrophilic ORAC, lipophilic ORAC, total ORAC

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2017
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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