HealthySPCNCT03926442
Spices, Inflammation and Vascular Response in Humans
A study testing Italian Herb meal, Cinnamon Meal and Pumpkin Spice meal in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The objectives of this study are: 1. To characterize the time course of herbs/spice action on endothelial function as measured by FMD over 24 h using a challenge meal paradigm. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Italian Herb meal, Cinnamon Meal and Pumpkin Spice meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 1 Feb 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 25 and 35 kg/m2
- Aged 18 years and older
- Able to provide informed consent and comply with study procedures
- Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
- Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
- People with no documented disease condition that would interfere with the study endpoints (ie., CVD, diabetes, hypertension, major organ diseases) or taking medication or dietary supplements that may interfere with study endpoints
Who cannot join
- Current smoker or marijuana user
- No history or presence of atherosclerosis/cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes.
- Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc)
- Unstable use of any medication/supplement, this could include marijuana used as -needed for medical reasons
- Have a history of cancer, except for non-melanoma skin cancer in past 5 years
- Addicted to drugs and/or alcohol (>4 drinks/day)
Show all 16Show fewer
- Have been exposed to any non-registered drug product within last 30 days.
- Working overnight (e.g. 3rd shift of overnight workers)
- Excessive exercisers or trained athletes
- Have allergies/intolerances to cinnamon, Italian herbs, etc.
- Extreme dietary habits (ie. vegetarian/vegan)
- Excessive coffee/tea drinker (>4 cups/day)
- Actively losing weight/ trying to lose weight (unstable body weight fluctuations of > 5 kg in 3 months)
- Donated blood within last 3 months
- Female who is pregnant, planning to be pregnant, breastfeeding
- Any condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Reason to Season: Flavors to Increase Vascular Health
The objectives of this study are:
- To characterize the time course of herbs/spice action on endothelial function as measured by FMD over 24 h using a challenge meal paradigm.
- To assess effects of herbs/spices on metabolic indices (ie., glucose, insulin), and inflammatory markers such as cytokines (ie., IL-6, TNF-alpha) and vascular adhesion molecules (ICAM and VCAM).
Read the detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This single-center clinical trial is a randomized, blinded, 4-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm to evaluate the effects of spice/herb intake on endothelial function, inflammation, insulin sensitivity / glucose handling and vascular function in overweight/obese adults after consuming a standardized challenge meal.
A planned sample size of 24 will be enrolled into the study. This study will require one initial screening visit and 4 study visits. This study will take approximately 4-5 weeks per subject to complete.
The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit. Shopping lists and meal plans will be provided to subjects, along with counseling by our study dietitians, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7-day run-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 4 treatment sequences. Treatment codes will be maintained by the principal investigator/study physician. All subjects will receive four treatments, once each on 4 different occasions and separated by at least 4 days. Italian Herb mix, Cinnamon, Pumpkin Spice or placebo will be provided with a standardized meal.
Each visit will last ~8 hours and subjects will be required to remain at the Clinical Unit for the duration of the visit. Blood samples will be collected at 0 (fasting) and at 0.5 h, 1 h, 2 h, 4 h, 5.5 h, 7 h and 24 h via a catheter placed on the non-dominant arm by a registered nurse. FMD or NIRS will be conducted at the CNRC or the HNRCA, respectively at 0 (fasting) and at 1 h, 2 h, 4 h, 5.5 h, 7 h and 24 h.
- Conditions
- Healthy
- Being tested
- Italian Herb meal, Cinnamon Meal, Pumpkin Spice meal, Placebo meal
- Keywords
- Spices, Herbs, Metabolic responses, Endothelial function, Inflammatory markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Italian Herb mealOther
Also called Italian Herb
Italian Herb in active breakfast meal
Cinnamon MealOther
Also called Cinnamon
Cinnamon in active breakfast meal
Pumpkin Spice mealOther
Also called Pumpkin Spice Mix
Pumpkin Spice Mix in active breakfast meal
Placebo mealOther
Also called Placebo
Placebo in breakfast meal
| Study group | Role | What they receive |
|---|---|---|
| Active1 | Experimental | Italian Herb in active breakfast meal Receives: Other: Italian Herb meal |
| Active2 | Experimental | Cinnamon in active breakfast meal Receives: Other: Cinnamon Meal |
| Active3 | Experimental | Pumpkin Spice Mix in active breakfast meal Receives: Other: Pumpkin Spice meal |
| Placebo Comparator | Placebo comparator | Placebo Breakfast Receives: Other: Placebo meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postprandial endothelial function among 4 treatments measured in percent flow mediated dilation
Vascular Assessments will be measured with Flow mediated vasodilation (FMD)
Measured: Baseline to 24 hours
Secondary outcomes (5)
Changes in Plasma Interleukin-1 β (IL-1β) concentration response among 4 treatments.
Inflammatory cytokines (Interleukin-1 β (IL-1β) will be measured using single target ELISA technology (R\&D Systems).
Measured: Baseline to 24 hours
Changes in Plasma Interleukin-6 (IL-6) concentration response among 4 treatments.
Inflammatory cytokines (Interleukin-6 (IL-6) will be measured using single target ELISA technology (R\&D Systems).
Measured: Baseline to 24 hours
Changes in Plasma Tumor Necrosis Factor-α (TNF-α) concentration response among 4 treatments.
Inflammatory cytokines (Tumor Necrosis Factor-α (TNF-α) will be measured using single target ELISA technology (R\&D Systems).
Measured: Baseline to 24 hours
Changes in Plasma intercellular adhesion molecule 1 (ICAM 1) concentration response among 4 treatments.
Inflammatory cytokines (intercellular adhesion molecule 1 (ICAM 1) will be measured using single target ELISA technology (R\&D Systems).
Measured: Baseline to 24 hours
Changes in Plasma vascular cell adhesion molecule 1 (VCAM 1) concentration response among 4 treatments.
Inflammatory cytokines (vascular cell adhesion molecule 1 (VCAM 1)) will be measured using single target ELISA technology (R\&D Systems).
Measured: baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start18 Apr 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926442
- Sponsor's protocol ID
- IRB2019-014
- Acronym
- SPC
- Status last verified
- Jul 2021
- First submitted
- 19 Apr 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang Y, Edirisinghe I, Burton-Freeman BM, Sandhu AK. Characterization and Pharmacokinetic Profile of Herbs and Spices' Phytochemicals over 24 h after Consumption in Overweight/Obese Adults. Mol Nutr Food Res. 2023 Jul;67(14):e2200785. doi: 10.1002/mnfr.202200785. Epub 2023 Jun 13.
PubMed 37310415Huang Y, Tsai MF, Thorat RS, Xiao D, Zhang X, Sandhu AK, Edirisinghe I, Burton-Freeman BM. Endothelial Function and Postprandial Glucose Control in Response to Test-Meals Containing Herbs and Spices in Adults With Overweight/Obesity. Front Nutr. 2022 Feb 22;9:811433. doi: 10.3389/fnut.2022.811433. eCollection 2022.
PubMed 35273988
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reason to Season: Flavors to Increase Vascular Health
- ClinicalTrials.gov ID
- NCT03926442
- Acronym / sponsor ID
- SPC / IRB2019-014
- Conditions
- Healthy
- Keywords
- Spices, Herbs, Metabolic responses, Endothelial function, Inflammatory markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 24 Apr 2019 (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.
The objectives of this study are:
- To characterize the time course of herbs/spice action on endothelial function as measured by FMD over 24 h using a challenge meal paradigm.
- To assess effects of herbs/spices on metabolic indices (ie., glucose, insulin), and inflammatory markers such as cytokines (ie., IL-6, TNF-alpha) and vascular adhesion molecules (ICAM and VCAM).
Detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This single-center clinical trial is a randomized, blinded, 4-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm to evaluate the effects of spice/herb intake on endothelial function, inflammation, insulin sensitivity / glucose handling and vascular function in overweight/obese adults after consuming a standardized challenge meal.
A planned sample size of 24 will be enrolled into the study. This study will require one initial screening visit and 4 study visits. This study will take approximately 4-5 weeks per subject to complete.
The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit. Shopping lists and meal plans will be provided to subjects, along with counseling by our study dietitians, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7-day run-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 4 treatment sequences. Treatment codes will be maintained by the principal investigator/study physician. All subjects will receive four treatments, once each on 4 different occasions and separated by at least 4 days. Italian Herb mix, Cinnamon, Pumpkin Spice or placebo will be provided with a standardized meal.
Each visit will last ~8 hours and subjects will be required to remain at the Clinical Unit for the duration of the visit. Blood samples will be collected at 0 (fasting) and at 0.5 h, 1 h, 2 h, 4 h, 5.5 h, 7 h and 24 h via a catheter placed on the non-dominant arm by a registered nurse. FMD or NIRS will be conducted at the CNRC or the HNRCA, respectively at 0 (fasting) and at 1 h, 2 h, 4 h, 5.5 h, 7 h and 24 h.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active1 | Experimental | Other: Italian Herb mealItalian Herb in active breakfast meal |
| Active2 | Experimental | Other: Cinnamon MealCinnamon in active breakfast meal |
| Active3 | Experimental | Other: Pumpkin Spice mealPumpkin Spice Mix in active breakfast meal |
| Placebo Comparator | Placebo comparator | Other: Placebo mealPlacebo Breakfast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI between 25 and 35 kg/m2
- Aged 18 years and older
- Able to provide informed consent and comply with study procedures
- Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
- Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
Key exclusion criteria (16 listed)
- Current smoker or marijuana user
- No history or presence of atherosclerosis/cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes.
- Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc)
- Unstable use of any medication/supplement, this could include marijuana used as -needed for medical reasons
- Have a history of cancer, except for non-melanoma skin cancer in past 5 years
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 |
|---|---|---|
| Italian Herb mealAlso: Italian HerbItalian Herb in active breakfast meal | Other | Active1 |
| Cinnamon MealAlso: CinnamonCinnamon in active breakfast meal | Other | Active2 |
| Pumpkin Spice mealAlso: Pumpkin Spice MixPumpkin Spice Mix in active breakfast meal | Other | Active3 |
| Placebo mealAlso: PlaceboPlacebo in breakfast meal | Other | Placebo Comparator |
Primary outcome
Changes in postprandial endothelial function among 4 treatments measured in percent flow mediated dilation
Time frame: Baseline to 24 hours
Vascular Assessments will be measured with Flow mediated vasodilation (FMD)
5 secondary outcomes
Changes in Plasma Interleukin-1 β (IL-1β) concentration response among 4 treatments.
Time frame: Baseline to 24 hours
Changes in Plasma Interleukin-6 (IL-6) concentration response among 4 treatments.
Time frame: Baseline to 24 hours
Changes in Plasma Tumor Necrosis Factor-α (TNF-α) concentration response among 4 treatments.
Time frame: Baseline to 24 hours
Changes in Plasma intercellular adhesion molecule 1 (ICAM 1) concentration response among 4 treatments.
Time frame: Baseline to 24 hours
Changes in Plasma vascular cell adhesion molecule 1 (VCAM 1) concentration response among 4 treatments.
Time frame: baseline to 24 hours
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 27 Jul 2021.
- Derived from this study: PubMed 37310415Huang Y, Edirisinghe I, Burton-Freeman BM, Sandhu AK. Characterization and Pharmacokinetic Profile of Herbs and Spices' Phytochemicals over 24 h after Consumption in Overweight/Obese Adults. Mol Nutr Food Res. 2023 Jul;67(14):e2200785. doi: 10.1002/mnfr.202200785. Epub 2023 Jun 13.
- Derived from this study: PubMed 35273988Huang Y, Tsai MF, Thorat RS, Xiao D, Zhang X, Sandhu AK, Edirisinghe I, Burton-Freeman BM. Endothelial Function and Postprandial Glucose Control in Response to Test-Meals Containing Herbs and Spices in Adults With Overweight/Obesity. Front Nutr. 2022 Feb 22;9:811433. doi: 10.3389/fnut.2022.811433. eCollection 2022.
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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.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Italian Herb meal, Cinnamon Meal and Pumpkin Spice meal in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 6 inclusion and 16 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 27 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
Changes in postprandial endothelial function among 4 treatments measured in percent flow mediated dilation (time frame: Baseline to 24 hours). 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 NCT03926442, which also lists 2 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 27 Jul 2021.