Back to results

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

Primary Purpose

Cardiovascular Disease, Inflammation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Controlled feeding diet

About this trial

This is an interventional prevention trial for Cardiovascular Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Penn State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

SD-Low

SD-Mod

SD-Culinary

Arm Description

Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a minimal amount of spices (<1g/day for all diets). Post prandial test meal will be contain minimal amounts of spice.

Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a moderate amount of spices (~3g/day in the 2100kcal diet). Post prandial test meal will be contain a moderate amount of spice.

Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a culinary dose of spices (6g/day in the 2100kcal diet). Post prandial test meal will be contain a culinary amount of spice.

Outcomes

Primary Outcome Measures

Change in lipid/lipoprotein profile

Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides

Secondary Outcome Measures

Central blood pressure

Brachial blood pressure

Augmentation index

Pulse wave velocity

HDL function

Change in Glucose

Change in Insulin

Diet satisfaction

Questionnaire

Change in flow mediated dilation

Only to be completed on men and postmenopausal women

Inflammation and immune fuction

Serum: IL-1β, IL-6, IL-10, IL-12p70, interferon-gamma, monocyte chemoattractant protein-1, macrophage inflammatory protein-1alpha, TNF-alpha, vascular endothelial growth factor

Ambulatory blood pressure

in vitro production of inflammatory cytokines and immune markers

effect of spice on in vitro production of TNF-alpha, IL-6,NF-κB, I-κB, MAP kinase, COX-2, iNOS from stimulated and unstimulated lipopolysaccharides in peripheral blood mononuclear cells. Activation status of macrophages.

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.

Full Information

NCT ID

NCT03064932

First Posted

February 13, 2017

Last Updated

August 15, 2023

Sponsor

Penn State University

Collaborators

McCormick Science Institute

1. Study Identification

Unique Protocol Identification Number

NCT03064932

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 25, 2017 (Actual)

Primary Completion Date

February 26, 2020 (Actual)

Study Completion Date

February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Penn State University

Collaborators

McCormick Science Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Disease, Inflammation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SD-Low

Arm Type

Active Comparator

Arm Description

Arm Title

SD-Mod

Arm Type

Experimental

Arm Description

Arm Title

SD-Culinary

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Controlled feeding diet

Intervention Description

Average American diet with different levels of spices

Primary Outcome Measure Information:

Title

Change in lipid/lipoprotein profile

Description

Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides

Time Frame

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 Outcome Measure Information:

Title

Central blood pressure

Time Frame

Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

Brachial blood pressure

Time Frame

Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

Augmentation index

Time Frame

Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

Pulse wave velocity

Time Frame

Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

HDL function

Time Frame

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)

Title

Change in Glucose

Time Frame

Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

Change in Insulin

Time Frame

Change from baseline in insulin at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

Diet satisfaction

Description

Questionnaire

Time Frame

After each 4 week diet period

Title

Change in flow mediated dilation

Description

Only to be completed on men and postmenopausal women

Time Frame

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)

Title

Inflammation and immune fuction

Description

Serum: IL-1β, IL-6, IL-10, IL-12p70, interferon-gamma, monocyte chemoattractant protein-1, macrophage inflammatory protein-1alpha, TNF-alpha, vascular endothelial growth factor

Time Frame

Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

Ambulatory blood pressure

Time Frame

Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

in vitro production of inflammatory cytokines and immune markers

Description

Time Frame

Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

Change in lipoprotein particle size and subclasses

Description

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.

Time Frame

Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Other Pre-specified Outcome Measures:

Title

Change in LDL oxidation

Time Frame

Change from baseline in LDL oxidation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

Title

Change in composition of the gut microbiome

Description

PCR quantification of total 16S rRNA

Time Frame

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)

Title

Change in urinary isoprostanes

Time Frame

Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Penny Kris-Etherton, PhD

Organizational Affiliation

Penn State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State University

City

University Park

State/Province

Pennsylvania

ZIP/Postal Code

16802

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36055770

Citation

Petersen KS, Anderson S, Chen See JR, Leister J, Kris-Etherton PM, Lamendella R. Herbs and Spices Modulate Gut Bacterial Composition in Adults At Risk for Cardiovascular Disease: Results of a Pre-Specified Exploratory Analysis from a Randomized, Crossover, Controlled-Feeding Study. J Nutr. 2022 Sep 2;152(11):2461-70. doi: 10.1093/jn/nxac201. Online ahead of print.

Results Reference

derived

PubMed Identifier

34601551

Citation

Oh ES, Petersen KS, Kris-Etherton PM, Rogers CJ. Four weeks of spice consumption lowers plasma proinflammatory cytokines and alters the function of monocytes in adults at risk of cardiometabolic disease: secondary outcome analysis in a 3-period, randomized, crossover, controlled feeding trial. Am J Clin Nutr. 2022 Jan 11;115(1):61-72. doi: 10.1093/ajcn/nqab331.

Results Reference

derived

PubMed Identifier

34510174

Citation

Petersen KS, Davis KM, Rogers CJ, Proctor DN, West SG, Kris-Etherton PM. Herbs and spices at a relatively high culinary dosage improves 24-hour ambulatory blood pressure in adults at risk of cardiometabolic diseases: a randomized, crossover, controlled-feeding study. Am J Clin Nutr. 2021 Dec 1;114(6):1936-1948. doi: 10.1093/ajcn/nqab291.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs