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Completed

NCT Number: NCT03064932

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled feeding diet

Other

Average American diet with different levels of spices

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • McCormick Science Institute

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2017
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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