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The objectives of this study are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active1 | Experimental | Italian Herb in active breakfast meal |
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| Active2 | Experimental | Cinnamon in active breakfast meal |
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| Active3 | Experimental | Pumpkin Spice Mix in active breakfast meal |
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| Placebo Comparator | Placebo Comparator | Placebo Breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Italian Herb meal | Other | Italian Herb in active breakfast meal |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in postprandial endothelial function among 4 treatments measured in percent flow mediated dilation | Vascular Assessments will be measured with Flow mediated vasodilation (FMD) | Baseline to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 24 hours |
| Changes in Plasma Interleukin-6 (IL-6) concentration response among 4 treatments. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britt Burton-Freeman, Ph.D | Illinois Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37310415 | Derived | 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. | |
| 35273988 | Derived | Huang 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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| Cinnamon Meal | Other | Cinnamon in active breakfast meal |
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| Pumpkin Spice meal | Other | Pumpkin Spice Mix in active breakfast meal |
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| Placebo meal | Other | Placebo in breakfast meal |
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Inflammatory cytokines (Interleukin-6 (IL-6) will be measured using single target ELISA technology (R&D Systems). |
| 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). | 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). | 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). | baseline to 24 hours |