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Spices, Inflammation and Vascular Response in Humans (SPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926442
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Clinical Nutrition Research Center, Illinois Institute of Technology

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Healthy Other: Italian Herb meal Other: Cinnamon Meal Other: Pumpkin Spice meal Other: Placebo meal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Reason to Season: Flavors to Increase Vascular Health
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : September 17, 2021
Estimated Study Completion Date : September 17, 2021

Arm Intervention/treatment
Experimental: Active1
Italian Herb in active breakfast meal
Other: Italian Herb meal
Italian Herb in active breakfast meal
Other Name: Italian Herb

Experimental: Active2
Cinnamon in active breakfast meal
Other: Cinnamon Meal
Cinnamon in active breakfast meal
Other Name: Cinnamon

Experimental: Active3
Pumpkin Spice Mix in active breakfast meal
Other: Pumpkin Spice meal
Pumpkin Spice Mix in active breakfast meal
Other Name: Pumpkin Spice Mix

Placebo Comparator: Placebo Comparator
Placebo Breakfast
Other: Placebo meal
Placebo in breakfast meal
Other Name: Placebo




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Changes in Plasma Interleukin-1 β (IL-1β) concentration response among 4 treatments. [ Time Frame: Baseline to 24 hours ]
    Inflammatory cytokines (Interleukin-1 β (IL-1β) will be measured using single target ELISA technology (R&D Systems).

  2. Changes in Plasma Interleukin-6 (IL-6) concentration response among 4 treatments. [ Time Frame: Baseline to 24 hours ]
    Inflammatory cytokines (Interleukin-6 (IL-6) will be measured using single target ELISA technology (R&D Systems).

  3. Changes in Plasma Tumor Necrosis Factor-α (TNF-α) concentration response among 4 treatments. [ Time Frame: Baseline to 24 hours ]
    Inflammatory cytokines (Tumor Necrosis Factor-α (TNF-α) will be measured using single target ELISA technology (R&D Systems).

  4. Changes in Plasma intercellular adhesion molecule 1 (ICAM 1) concentration response among 4 treatments. [ Time Frame: Baseline to 24 hours ]
    Inflammatory cytokines (intercellular adhesion molecule 1 (ICAM 1) will be measured using single target ELISA technology (R&D Systems).

  5. Changes in Plasma vascular cell adhesion molecule 1 (VCAM 1) concentration response among 4 treatments. [ Time Frame: baseline to 24 hours ]
    Inflammatory cytokines (vascular cell adhesion molecule 1 (VCAM 1)) will be measured using single target ELISA technology (R&D Systems).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926442


Locations
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United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Clinical Nutrition Research Center, Illinois Institute of Technology
Investigators
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Principal Investigator: Britt Burton-Freeman, Ph.D Illinois Institute of Technology
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Responsible Party: Clinical Nutrition Research Center, Illinois Institute of Technology
ClinicalTrials.gov Identifier: NCT03926442    
Other Study ID Numbers: IRB2019-014
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinical Nutrition Research Center, Illinois Institute of Technology:
Spices
Herbs
Metabolic responses
Endothelial function
Inflammatory markers