Reason to Season; Flavors to Increase Vascular Health
SPC
1 other identifier
interventional
28
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2019
CompletedFirst Submitted
Initial submission to the registry
April 6, 2020
CompletedFirst Posted
Study publicly available on registry
April 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedJuly 27, 2021
July 1, 2021
1.8 years
April 6, 2020
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To characterize the time course of herbs/spice action on endothelial function as measured by Flow Mediated Vasodilation (FMD) over 24 h using a challenge meal paradigm individualized per subject energy requirements to maintain body weight.
Flow mediated vasodilation (FMD): Ultrasound imaging of the brachial artery is a non-invasive technique that assesses endothelial-dependent relaxation and is used as a surrogate marker of large vessel (macrovascular) endothelial function. FMD will be studied in the brachial (arm) artery of all subjects using standardized methods recommended by the American College of Cardiology
Baseline(T0)-24 hours
Secondary Outcomes (3)
Changes in plasma glucose concentration-response between 4 treatments
Baseline(T0)-24 hours
Changes in plasma insulin concentration-response between 4 treatments
Baseline(T0)-24 hours
Changes in inflammation signaling response between 4 treatments
Baseline (T0)-7 hours
Other Outcomes (1)
To assess effects of herbs/spices on inflammatory markers
Baseline (T0)-24 hours
Study Arms (4)
Control meal
SHAM COMPARATORPancake
Control meal + Cinnamon
ACTIVE COMPARATORPancake seasoned with cinnamon
Control meal + Italian herb mix
ACTIVE COMPARATORPancake seasoned with Italian herb mix
Control meal + Active-Herbs/Spice mix
ACTIVE COMPARATORPancake seasoned with pumpkin spice
Interventions
The breakfast meal includes a Taiwanese style pancake plus a side of hash browns with ketchup. Every meal will be individualized to meet the 30% of the energy requirement of subjects based on the Harris benedict equation.
The breakfast meal includes a Taiwanese style pancake seasoned with grounded cinnamon plus a side of hash browns with ketchup. Every meal will be individualized to meet the 30% of the energy requirement of subjects based on the Harris benedict equation.
The breakfast meal includes a Taiwanese style pancake seasoned with Italian herbs plus a side of hash browns with ketchup. Every meal will be individualized to meet the 30% of the energy requirement of subjects based on the Harris benedict equation.
The breakfast meal includes a Taiwanese style pancake seasoned with pumpkin spices plus a side of hash browns with ketchup. Every meal will be individualized to meet the 30% of the energy requirement of subjects based on the Harris benedict equation.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Center
Chicago, Illinois, 60616, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Britt Burton-Freeman, Ph.D
Illinois Insititute of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2020
First Posted
April 9, 2020
Study Start
April 18, 2019
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
July 27, 2021
Record last verified: 2021-07