Clinical trial NCT03926442: Spices, Inflammation and Vascular Response in Humans
Official title: Reason to Season: Flavors to Increase Vascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Spices
Herbs
Metabolic responses
Endothelial function
Inflammatory markers
Lead sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).

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.

Eligibility 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

Primary outcomes:
measure: Changes in postprandial endothelial function among 4 treatments measured in percent flow mediated dilation
timeFrame: Baseline to 24 hours
Secondary outcomes:
measure: Changes in Plasma Interleukin-1 β (IL-1β) concentration response among 4 treatments.
timeFrame: Baseline to 24 hours
measure: Changes in Plasma Interleukin-6 (IL-6) concentration response among 4 treatments.
timeFrame: Baseline to 24 hours
measure: Changes in Plasma Tumor Necrosis Factor-α (TNF-α) concentration response among 4 treatments.
timeFrame: Baseline to 24 hours
measure: Changes in Plasma intercellular adhesion molecule 1 (ICAM 1) concentration response among 4 treatments.
timeFrame: Baseline to 24 hours
measure: Changes in Plasma vascular cell adhesion molecule 1 (VCAM 1) concentration response among 4 treatments.
timeFrame: baseline to 24 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Clinical Nutrition Research Center
state: Illinois
Study officials:
affiliation: Illinois Institute of Technology
name: Britt Burton-Freeman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.