The Acute Effect of Spices on Vascular Health

Not Applicable

Completed

• Conditions: Oxidative Stress
• Interventions: Other: Herbs and spices; Other: High fat meal

• Registration Number: NCT03064958
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-09-13
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-27
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spice 6g	High fat meal	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.
Control	High fat meal	Consumption of a high fat meal (1000kcal, 45g fat)
Spice 2g	High fat meal	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.
Spice 2g	Herbs and spices	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.
Spice 6g	Herbs and spices	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States