The Effect of Spice Consumption on Postprandial Vascular Function

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Other: Spice blend

Study type: Interventional

Funder types: Other

Identifiers

NCT03063320

PKE Spice PP

Details and patient eligibility

About

A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.

Full description

A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.

Enrollment: 43 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Men and postmenopausal women Overweight or obese (25-35kg/m2) Non-smoking Waist circumference >= 94cm for men and >=80cm for women

At least one other of the following:

• LDL- cholesterol >130mg/dL
• CRP >1mg/L
• Triglycerides >=150mg/dL
• HDL <40mg/dL for men or <50mg/dL for women
• Systolic blood pressure >= 130mmHg or diastolic >= 85mmHg
• Fasting glucose >=100mg/dL

Exclusion criteria

• Diabetes (fasting glucose >126mg/dL)
• Hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
• Prescribed anti-hypertensive or glucose lowering drugs
• Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease
• Use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals
• Pregnancy or lactation
• Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
• Vegetarianism

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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43 participants in 3 patient groups

Low Spice

Active Comparator group

Description:

The test meal (\~1200kcal and 44g fat) will contain \~0.6g of spice blend

Treatment:

Other: Spice blend

Moderate Spice

Experimental group

Description:

The test meal (\~1200kcal and 44g fat) will contain \~3.7g of spice blend

Treatment:

Other: Spice blend

Culinary Spice

Experimental group

Description:

The test meal (\~1200kcal and 44g fat) will contain \~7.4g of spice blend

Treatment:

Other: Spice blend