The Effect of Spice Consumption on Postprandial Vascular Function

NCT03063320 | Completed

• 1 other identifier: PKE Spice PP
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Change in flow mediated dilation

  Endothelial function measured by FMD

  Change from baseline at 2 hours and 4 hours after meal consumption

Secondary Outcomes (6)

• Lipid and lipoproteins

  Change from baseline during the 4 hours after meal consumption

• Plasma Inflammatory cytokines

  Change from baseline during the 4 hours after meal consumption

• Inflammatory cytokines in isolated peripheral blood mononuclear cells

  Change from baseline during the 4 hours after meal consumption

• Glucose

  Change from baseline during the 4 hours after meal consumption

• Insulin

  Change from baseline during the 4 hours after meal consumption

Study Arms (3)

Low Spice

ACTIVE COMPARATOR

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

Other: Spice blend

Moderate Spice

EXPERIMENTAL

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

Other: Spice blend

Culinary Spice

EXPERIMENTAL

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

Other: Spice blend

Interventions

Spice blend OTHER

Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon

Culinary Spice; Low Spice; Moderate Spice

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Study Officials

• Penny M Kris-Etherton, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Person assessing the outcome measures will be blinded to participant allocation
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 period randomized cross over

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: January 25, 2017
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)