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The Acute Effect of Spices on Vascular Health

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ClinicalTrials.gov Identifier: NCT03064958
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
McCormick Science Institute
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Other: Herbs and spices Other: High fat meal Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Postprandial Effects of a High Fat Meal Containing Spices on Endothelial Function: a Pilot Study
Actual Study Start Date : September 13, 2016
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : March 29, 2018

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: Herbs and spices
Mix of commonly used herbs and spices

Other: High fat meal
Meal containing 1000kcal and 45g fat

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: Herbs and spices
Mix of commonly used herbs and spices

Other: High fat meal
Meal containing 1000kcal and 45g fat




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Lipids and lipoproteins [ Time Frame: Change from baseline during the 4 hours after meal consumption ]
  2. Plasma Inflammatory cytokines [ Time Frame: Change from baseline during the 4 hours after meal consumption ]
  3. Inflammatory cytokines in isolated peripheral blood mononuclear cells [ Time Frame: Change from baseline during the 4 hours after meal consumption ]
  4. Glucose [ Time Frame: Change from baseline during the 4 hours after meal consumption ]
  5. Insulin [ Time Frame: Change from baseline during the 4 hours after meal consumption ]
  6. Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC) [ Time Frame: Change from baseline during the 4 hours after meal consumption ]
  7. Oxidative stress [ Time Frame: Change from baseline during the 4 hours after meal consumption ]
  8. Plasma nitrite and nitrate [ Time Frame: Change from baseline during the 4 hours after meal consumption ]
  9. Plasma and Urine Metabolomic profiling [ Time Frame: Change from baseline during the 4 hours after meal consumption ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064958


Locations
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United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
McCormick Science Institute

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Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT03064958     History of Changes
Other Study ID Numbers: PKE SPICE PILOT
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Penny Kris-Etherton, Penn State University:
glucose regulation
lipids
Immune markers
Endothelium, Vascular