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Completed

NCT Number: NCT03064958

The Acute Effect of Spices on Vascular Health

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.

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Herbs and spices

Other

Mix of commonly used herbs and spices

high fat meal

Other

Meal containing 1000kcal and 45g fat

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • McCormick Science Institute

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2017
Registry last updated
Aug 21, 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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