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

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ClinicalTrials.gov Identifier: NCT03064932
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
McCormick Science Institute
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Inflammation Other: Controlled feeding diet Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Chronic Consumption of Popular Spices on Risk Factors for Cardiovascular Disease (CVD), Inflammation & Immune Function, and Diet Satisfaction
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: SD-Low

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.

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

Experimental: SD-Mod

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.

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

Experimental: SD-Culinary

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.

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




Primary Outcome Measures :
  1. Change in lipid/lipoprotein profile [ 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) ]
    Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. Diet satisfaction [ Time Frame: After each 4 week diet period ]
    Questionnaire

  9. Change in flow mediated dilation [ 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) ]
    Only to be completed on men and postmenopausal women

  10. Inflammation and immune fuction [ Time Frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) ]
    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

  11. 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) ]
  12. in vitro production of inflammatory cytokines and immune markers [ Time Frame: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) ]
    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.

  13. Change in lipoprotein particle size and subclasses [ 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) ]
    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.


Other Outcome Measures:
  1. 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) ]
  2. Change in composition of the gut microbiome [ 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) ]
    PCR quantification of total 16S rRNA

  3. 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) ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064932


Contacts
Contact: Kristina Petersen, PhD 814-863-8622 kup63@psu.edu
Contact: Jennifer Fleming 814-863-8056 jas58@psu.edu

Locations
United States, Pennsylvania
Penn State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Kristina Petersen, PhD    814-863-8622    kup63@psu.edu   
Principal Investigator: Penny Kris-Etherton, PhD         
Sub-Investigator: Sheila West, PhD         
Sub-Investigator: Connie Rogers, PhD         
Sub-Investigator: David Proctor, PhD         
Sub-Investigator: Kristina Petersen, PhD         
Sponsors and Collaborators
Penn State University
McCormick Science Institute
Investigators
Principal Investigator: Penny Kris-Etherton, PhD Penn State University

Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT03064932     History of Changes
Other Study ID Numbers: PKE SPICE
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Pathologic Processes