Spices, Inflammation and Vascular Response in Humans

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT03926442

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

28

Starts

2019-04-18

Expected to finish

2021-02-01

Last updated by the study team

2021-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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