Reason to Season; Flavors to Increase Vascular Health

Completed · Not applicable

Conditions studied: Overweight and Obesity, Healthy

In brief

Scientific evidence is growing on the health benefits of herbs/spices. The study is interested in understanding how various herb and spice blends influence the function of blood vessels. The study is also interested in how blood sugar, the insulin hormone and immune cells may be related to how well the blood vessels function. Herbs and spices have components called phytochemicals that may be related to how well blood vessels function. The study is planned to investigate these relationships. After qualifying to participate in the research study, participants will be asked to come to the Clinical Nutrition Research Center (CNRC) for four on-site Study Days, each lasting for about 8 hours with a 40 min followup to measure vessels' function the next morning. On each Study Day, different amounts of herbs/spices will be included in a breakfast meal. The herbs and spices are purchased in the grocery store and are Italian herbs, cinnamon, and a mix of pumpkin pie spices (cinnamon, ginger, clove, nutmeg). All meals will be prepared in the CNRC's kitchen using foods and ingredients purchased at the local grocery store. Blood collection and blood vessel function tests will be performed during the Study Day using typical procedures used in hospitals, doctor offices, and clinics.

Key facts

Study ID

NCT04339114

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…

• Body Mass Index between 25 and 35 kg/m2
• Aged over 18 years old
• 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.
• People with no documented disease condition that would interfere with the study endpoints (ie., Cardiovascular disease (CVD), diabetes, hypertension (diagnosed high blood pressure), major organ diseases) or taking medication or dietary supplements that may interfere with study endpoints.
• Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
• Premenopausal women are studied at the same time of the month during the follicular phase of their menstrual cycle (first 14 days of cycle).

You may not qualify if…

• Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped >2 years
• Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes
• Unstable use of any medication/supplement - Have a history of cancer, except for non-melanoma skin cancer within 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)
• Have allergies/intolerances to cinnamon, Italian herbs, or other spices or study foods
• Excessive exercisers or trained athletes
• Extreme dietary habits (i.e., vegan)
• Excessive coffee/tea drinker (> 4cups/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, or breastfeeding
• The individual has a 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 the interpretation of the study results or put the person at undue risk.

Where it is running

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

Full record on ClinicalTrials.gov

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