Cardiovascular Risk FactorNCT03063320
The Effect of Spice Consumption on Postprandial Vascular Function
A study testing Spice blend in people with Cardiovascular Risk Factor, run by Penn State University at 1 site in United States.
Trial summary
A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Spice blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 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
- Men and postmenopausal women Overweight or obese (25-35kg/m2) Non-smoking 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 Postprandial Vascular Function
A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.
Read the detailed description
A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Spice blend
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spice blendOther
Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon
| Study group | Role | What they receive |
|---|---|---|
| Low Spice | Active comparator | The test meal (~1200kcal and 44g fat) will contain ~0.6g of spice blend Receives: Other: Spice blend |
| Moderate Spice | Experimental | The test meal (~1200kcal and 44g fat) will contain ~3.7g of spice blend Receives: Other: Spice blend |
| Culinary Spice | Experimental | The test meal (~1200kcal and 44g fat) will contain ~7.4g of spice blend Receives: Other: Spice blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in flow mediated dilation
Endothelial function measured by FMD
Measured: Change from baseline at 2 hours and 4 hours after meal consumption
Secondary outcomes (6)
Lipid and lipoproteins
Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides
Measured: Change from baseline during the 4 hours after meal consumption
Plasma Inflammatory cytokines
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 during the 4 hours after meal consumption
Inflammatory cytokines in isolated peripheral blood mononuclear cells
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 during the 4 hours after meal consumption
Glucose
Plasma glucose
Measured: Change from baseline during the 4 hours after meal consumption
Insulin
Plasma insulin
Measured: Change from baseline during the 4 hours after meal consumption
Plasma antioxidants
hydrophilic ORAC, lipophilic ORAC, total ORAC
Measured: Change from baseline during the 4 hours after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 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 (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- 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
- Model description
- 3 period randomized cross over
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063320
- Sponsor's protocol ID
- PKE Spice PP
- Status last verified
- Sep 2023
- First submitted
- 21 Feb 2017
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Damani JJ, Kris-Etherton PM, Rogers CJ, Proctor DN, Davis KM, Petersen KS. The Effect of Meals with Culinary Doses of Herbs and Spices on Postprandial Endothelial Function, Lipemia, and Glycemia after 4-Week Exposure to Herb- and Spice-Containing Diets: A Secondary Analysis of a Randomized, Crossover, Controlled-Feeding Study. Curr Dev Nutr. 2026 Jul 21;10(8):109441. doi: 10.1016/j.cdnut.2026.109441. eCollection 2026 Aug.
PubMed 42602914
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 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 Postprandial Vascular Function
- ClinicalTrials.gov ID
- NCT03063320
- Acronym / sponsor ID
- PKE Spice PP
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 24 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.
A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.
Detailed description
A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 period randomized cross over
| Arm | Type | Receives |
|---|---|---|
| Low Spice | Active comparator | Other: Spice blendThe test meal (~1200kcal and 44g fat) will contain ~0.6g of spice blend |
| Moderate Spice | Experimental | Other: Spice blendThe test meal (~1200kcal and 44g fat) will contain ~3.7g of spice blend |
| Culinary Spice | Experimental | Other: Spice blendThe test meal (~1200kcal and 44g fat) will contain ~7.4g of spice blend |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and postmenopausal women Overweight or obese (25-35kg/m2) Non-smoking Waist circumference >= 94cm for men and >=80cm for women
- LDL- cholesterol >130mg/dL
- CRP >1mg/L
- Triglycerides >=150mg/dL
- HDL <40mg/dL for men or <50mg/dL for women
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 |
|---|---|---|
| Spice blendTest spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon | Other | Culinary Spice, Low Spice, Moderate Spice |
Primary outcome
Change in flow mediated dilation
Time frame: Change from baseline at 2 hours and 4 hours after meal consumption
Endothelial function measured by FMD
6 secondary outcomes
Lipid and lipoproteins
Time frame: Change from baseline during the 4 hours after meal consumption
Plasma Inflammatory cytokines
Time frame: Change from baseline during the 4 hours after meal consumption
Inflammatory cytokines in isolated peripheral blood mononuclear cells
Time frame: Change from baseline during the 4 hours after meal consumption
Glucose
Time frame: Change from baseline during the 4 hours after meal consumption
Insulin
Time frame: Change from baseline during the 4 hours after meal consumption
Plasma antioxidants
Time frame: Change from baseline during the 4 hours after meal consumption
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 Sep 2023.
- Derived from this study: PubMed 42602914Damani JJ, Kris-Etherton PM, Rogers CJ, Proctor DN, Davis KM, Petersen KS. The Effect of Meals with Culinary Doses of Herbs and Spices on Postprandial Endothelial Function, Lipemia, and Glycemia after 4-Week Exposure to Herb- and Spice-Containing Diets: A Secondary Analysis of a Randomized, Crossover, Controlled-Feeding Study. Curr Dev Nutr. 2026 Jul 21;10(8):109441. doi: 10.1016/j.cdnut.2026.109441. eCollection 2026 Aug.
- 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 M 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 testing Spice blend in people with Cardiovascular Risk Factor, 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 8 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 Sep 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 flow mediated dilation (time frame: Change from baseline at 2 hours and 4 hours after meal consumption). 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 NCT03063320, which also lists 1 linked publication.
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 Sep 2023.