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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Spices, Inflammation and Vascular Response in Humans

Clinicaltrials.gov identifier NCT03926442

Recruitment Status Active, not recruiting

First Posted April 24, 2019

Last update posted July 14, 2020

Study Description

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:Healthy
  • Intervention/Treatment: Other: Italian Herb meal
    Other: Cinnamon Meal
    Other: Pumpkin Spice meal
    Other: Placebo meal
  • Phase: N/A
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
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: September 2021
  • Estimated Study Completion Date: September 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Active1
Italian Herb in active breakfast meal
Other: Italian Herb meal
Italian Herb in active breakfast meal
Experimental: Active2
Cinnamon in active breakfast meal
Other: Cinnamon Meal
Cinnamon in active breakfast meal
Experimental: Active3
Pumpkin Spice Mix in active breakfast meal
Other: Pumpkin Spice meal
Pumpkin Spice Mix in active breakfast meal
Placebo Comparator: Placebo Comparator
Placebo Breakfast
Other: Placebo meal
Placebo in breakfast meal
Outcome Measures
  • 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).
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

United States, Illinois
Clinical Nutrition Research Center
Chicago

Sponsors and Collaborators

Clinical Nutrition Research Center, Illinois Institute of Technology

Investigators

Principal Investigator: Britt Burton-Freeman, Ph.D Illinois Institute of Technology

More Information
  • Responsible Party: Clinical Nutrition Research Center, Illinois Institute of Technology
  • ClinicalTrials.gov Identifier: NCT03926442 History of Changes
  • Other Study ID Numbers: IRB2019-014
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 14, 2020
  • Last Verified: July 2020
  • 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