The Acute Effect of Spices on Vascular Health

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064958
• Other study ID #: PKE SPICE PILOT
• Status: Completed
• Phase: N/A
• Start date: September 13, 2016
• Est. completion date: March 29, 2018

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Other:
• Herbs and spices
Mix of commonly used herbs and spices
• High fat meal
Meal containing 1000kcal and 45g fat

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	McCormick Science Institute

Country where clinical trial is conducted

United States, 

Outcome

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