Effect of a Spice Blend on Cardiovascular Risk Factors and Diet Satisfaction

Inflammation Clinical Trial

Official title:

The Effect of Chronic Consumption of Popular Spices on Risk Factors for Cardiovascular Disease (CVD), Inflammation & Immune Function, and Diet Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064932
• Other study ID #: PKE SPICE
• Status: Completed
• Phase: N/A
• Start date: January 25, 2017
• Est. completion date: February 26, 2020

Study information

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

Clinical Trial Summary

This study is a randomized 3-period crossover, controlled feeding study designed to evaluate the effects of the most commonly consumed spices in the U.S. on CVD risk factors, inflammation & immune function, and diet satisfaction in participants at risk for CVD.

Description:

A 3-period randomized crossover controlled-feeding study will be conducted. Participants will be randomly assigned to receive each 4-week treatment (diet) in random order. Each test diet period will be separated by a standard 4-week compliance break. Data collection will be conducted across at baseline (start of study) and the end of each diet period to assess the effects of chronic spice consumption on selected cardiovascular endpoints.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• overweight or obese (25-35kg/m2)

• non-smoking

• male or female

• 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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Inflammation

Intervention

Other:
• Controlled feeding diet
Average American diet with different levels of spices

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
Other	Change in LDL oxidation		Change from baseline in LDL oxidation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Other	Change in composition of the gut microbiome	PCR quantification of total 16S rRNA	Change from baseline in composition of the gut microbiome at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Other	Change in urinary isoprostanes		Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Primary	Change in lipid/lipoprotein profile	Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides	Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Central blood pressure		Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Brachial blood pressure		Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Augmentation index		Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Pulse wave velocity		Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	HDL function		Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Change in Glucose		Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Change in Insulin		Change from baseline in insulin at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Diet satisfaction	Questionnaire	After each 4 week diet period
Secondary	Change in flow mediated dilation	Only to be completed on men and postmenopausal women	Change from baseline in flow mediated dilation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Inflammation and immune fuction	Serum: IL-1ß, IL-6, IL-10, IL-12p70, interferon-gamma, monocyte chemoattractant protein-1, macrophage inflammatory protein-1alpha, TNF-alpha, vascular endothelial growth factor	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Ambulatory blood pressure		Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	in vitro production of inflammatory cytokines and immune markers	effect of spice on in vitro production of TNF-alpha, IL-6,NF-?B, I-?B, MAP kinase, COX-2, iNOS from stimulated and unstimulated lipopolysaccharides in peripheral blood mononuclear cells. Activation status of macrophages.	Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Secondary	Change in lipoprotein particle size and subclasses	LDL, LDLR [i.e., LDL-(IDL + Lp(a))], Lp(a), IDL, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non HDL, Remnant Lipoproteins, LDL4, LDL3, LDL2, ApoB100, ApoA1, ApoB100:A1.	Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)