Status:
COMPLETED
Reason to Season; Flavors to Increase Vascular Health
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborating Sponsors:
McCormick Science Institute
Conditions:
Overweight and Obesity
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This clinical trial is a single-center randomized, blinded, multi-arm, within subjects, cross over design and features a repeated postprandial sampling paradigm to evaluate the effects of herbs/spices...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
April 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04339114
Start Date
April 18 2019
End Date
February 1 2021
Last Update
July 27 2021
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616