Cardiovascular DiseaseNCT03064932
Effect of a Spice Blend on Cardiovascular Risk Factors and Diet Satisfaction
A study of Cardiovascular Disease and Inflammation, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Inflammation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2017to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: The Effect of Chronic Consumption of Popular Spices on Risk Factors for Cardiovascular Disease (CVD), Inflammation & Immune Function, 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.
Read the 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.
- Conditions
- Cardiovascular Disease, Inflammation
- Being tested
- Controlled feeding diet
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled feeding dietOther
Average American diet with different levels of spices
| Study group | Role | What they receive |
|---|---|---|
| SD-Low | Active comparator | 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. Receives: Other: Controlled feeding diet |
| SD-Mod | Experimental | 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. Receives: Other: Controlled feeding diet |
| SD-Culinary | Experimental | 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. Receives: Other: Controlled feeding diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipid/lipoprotein profile
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Measured: 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 outcomes (13)
Central blood pressure
Measured: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Brachial blood pressure
Measured: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Augmentation index
Measured: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Pulse wave velocity
Measured: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
HDL function
Measured: 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)
Change in Glucose
Measured: Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Change in Insulin
Measured: Change from baseline in insulin at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Diet satisfaction
Questionnaire
Measured: After each 4 week diet period
Change in flow mediated dilation
Only to be completed on men and postmenopausal women
Measured: 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)
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
Measured: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Ambulatory blood pressure
Measured: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
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.
Measured: Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
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.
Measured: Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start25 Jan 2017
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick Science Institute
- Responsible party
- Sponsor
- Investigators
- Penny Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064932
- Sponsor's protocol ID
- PKE SPICE
- Status last verified
- Aug 2023
- First submitted
- 13 Feb 2017
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 CVD: Results of a Prespecified Exploratory Analysis from a Randomized, Crossover, Controlled-Feeding Study. J Nutr. 2022 Nov;152(11):2461-2470. doi: 10.1093/jn/nxac201. Epub 2022 Sep 2.
PubMed 36774112Oh 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.
PubMed 34601551Petersen 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.
PubMed 34510174
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Consumption of Popular Spices on Risk Factors for Cardiovascular Disease (CVD), Inflammation & Immune Function, and Diet Satisfaction
- ClinicalTrials.gov ID
- NCT03064932
- Acronym / sponsor ID
- PKE SPICE
- Conditions
- Cardiovascular Disease, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- McCormick Science Institute
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SD-Low | Active comparator | Other: Controlled feeding dietAverage 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. |
| SD-Mod | Experimental | Other: Controlled feeding dietAverage 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. |
| SD-Culinary | Experimental | Other: Controlled feeding dietAverage 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled feeding dietAverage American diet with different levels of spices | Other | SD-Culinary, SD-Low, SD-Mod |
Primary outcome
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
13 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Diet satisfaction
Time frame: After each 4 week diet period
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Derived from this study: PubMed 36774112Petersen 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 CVD: Results of a Prespecified Exploratory Analysis from a Randomized, Crossover, Controlled-Feeding Study. J Nutr. 2022 Nov;152(11):2461-2470. doi: 10.1093/jn/nxac201. Epub 2022 Sep 2.
- Derived from this study: PubMed 34601551Oh 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.
- Derived from this study: PubMed 34510174Petersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny Kris-Etherton, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiovascular Disease and Inflammation, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064932, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.