The Acute Effect of Spices on Vascular Health

August 16, 2023 updated by: Penn State University

The Postprandial Effects of a High Fat Meal Containing Spices on Endothelial Function: a Pilot Study

The investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. In random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. Between each treatment there will be a washout period of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 3-period randomized controlled crossover study will be conducted to investigate the postprandial effects of a high fat meal with spices on endothelial function, lipids/lipoproteins, immune function, plasma antioxidants and markers of oxidative stress. Metabolomic profiling will also be conducted. In random order participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spices or a high fat meal containing 6g of spices with a 3 day washout period between each treatment. The following spices will be incorporated into the meal black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme.

Endothelial function will be measured by flow mediated dilation of the brachial artery in the fasting state and 2 and 4 hours after the meal. Participants will also provide a fasting blood sample and samples will also be taken at 1, 2, 3 and 4 hours after the meal.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • male aged 40-65 years
  • BMI 25-35kg/m2
  • nonsmoking
  • waist circumference =/> 94cm and at least one other CVD risk factor (elevated LDL-C (> 130 mg/dL), CRP (> 1 mg/L), elevated Triglycerides (≥ 150 mg/dL), reduced HDL-cholesterol (< 40 mg/dL), elevated blood pressure (systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg), elevated fasting glucose (≥ 100 mg/dL))
  • low herb/spice consumers (consumption <1/day)

Exclusion Criteria:

  • Chronic disease risk factors that are diagnostic of diabetes (fasting glucose > 126 mg/dL) or hypertension (SBP >160 mm Hg or DBP > 100 mm Hg).
  • Prescription of anti-hypertensive or glucose lowering drugs.
  • Established CVD, stroke, diabetes, liver, kidney or autoimmune disease
  • Use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals
  • weight loss of ≥10% of body weight within the 6 months prior to enrolling in the study
  • vegetarianism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Consumption of a high fat meal (1000kcal, 45g fat)
Other: High fat meal
Meal containing 1000kcal and 45g fat
Experimental: Spice 2g
Consumption of a high fat meal (1000kcal, 45g fat) with 2g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.
Other: High fat meal
Meal containing 1000kcal and 45g fat
Other: Herbs and spices
Mix of commonly used herbs and spices
Experimental: Spice 6g
Consumption of a high fat meal (1000kcal, 45g fat) with 6g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.
Other: High fat meal
Meal containing 1000kcal and 45g fat
Other: Herbs and spices
Mix of commonly used herbs and spices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery
Time Frame: Change from baseline at 2 hours and 4 hours after meal consumption
Change from baseline at 2 hours and 4 hours after meal consumption

Secondary Outcome Measures

Outcome Measure
Time Frame
Lipids and lipoproteins
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption
Plasma Inflammatory cytokines
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption
Inflammatory cytokines in isolated peripheral blood mononuclear cells
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption
Glucose
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption
Insulin
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption
Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC)
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption
Oxidative stress
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption
Plasma nitrite and nitrate
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption
Plasma and Urine Metabolomic profiling
Time Frame: Change from baseline during the 4 hours after meal consumption
Change from baseline during the 4 hours after meal consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

McCormick Science Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2016

Primary Completion (Actual)

March 29, 2018

Study Completion (Actual)

March 29, 2018

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PKE SPICE PILOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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