Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04339114 |
| Other study ID # |
IRB 2019-014 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 18, 2019 |
| Est. completion date |
February 1, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Clinical Nutrition Research Center, Illinois Institute of Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 on vascular function in individuals who are overweight or moderately obese after
consuming a standardized challenge meal. Subjects will undergo 4 Study Days at least 3 days
apart. On each Study Day subject will receive a standardized meal made with: salt and pepper
only (Control condition) or the same meal with up to 6 gram herbs/spice mix or Italian herb
mix or cinnamon.Each Study Day will last about 8 h with a 40 min follow up the following
morning to complete a 24 h set of procedures. The 24 h assessment allows for assessment of
clinical effects over an extended time frame.
STUDY PROCEDURES:
1. Screening Visit:
Interested subjects will be asked to come to the Clinical Nutrition Research Center
(CNRC) on the IIT (Illinois Tech) Campus, Chicago, IL, where the study will take place
for all in person visits. The screening visit is the first visit and will be used to
determine if an interested person is eligible to participate in the study. The screening
visit will take 2 hours. Prospective subjects must read, sign and date a written
Institutional Review Board approved Informed Consent Form prior to performing any study
procedure. One of our Study investigators will go through the inform consent (ICF) with
subject comprehensively to explain all study related activities as mentioned in the ICF
form.
At the on-site screening visit, subject will be asked to arrive after overnight fasting
for 10-14 hours and be well-hydrated. Subjects will be instructed to drink plenty of
water the 24 hours before the screening visit to ensure they are well hydrated (ie., aim
for intake of at least 8-10 cups over 24 h). They will also be asked to abstain from
vigorous exercise 12 h before the visit. Light activity is acceptable. A series of
procedures will be conducted to determine eligibility to participate in the study,
including venous or capillary blood sampling (by finger prick) to test blood glucose (to
ensure fasting status and inclusion criteria), anthropometric measurements (height,
weight, waist circumference, body composition), Body Mass Index (BMI, calculated from
height and weight) calculation, vital sign measurements (blood pressure and heart rate),
body temperature measurement (by ear thermometer), and completion of a series of
questionnaires relating to their general health and lifestyle. For vital sign
measurements, subjects will sit in a comfortable chair, feet uncrossed and on the floor
and will be asked to rest quietly for 5 minutes before measuring blood pressure and
heart rate. Arm vein will be assessed using a vein access scale test.
Based on the results of fasting blood glucose concentration, the questionnaires, and
health evaluation, subjects who meet the inclusion and none of the exclusion criteria
will be invited to participate in the study.
Subjects who are eligible and accept the invitation to participate will be counseled on
following a limited polyphenolic diet throughout the duration of their participation,
although more strict guidelines will be imposed during the 3 days prior to each study
visit. Shopping lists and meal plans will be provided to subjects, along with counseling
by our staff, to help subjects adhere to the limited polyphenolic diet. Subjects will be
asked not to take any allergy medications and/or any pain medications such as Aspirin,
Excedrin, Ibuprofen (Advil, Motrin, Nuprin), Naproxen, Aleve within 48 hours of each
scheduled study days. Tylenol is allowed. The visit will be rescheduled when
allergy/pain medication is needed within 48 hours prior to study days.
Before leaving the CNRC, subjects will be provided instructions for "How to prepare for
study day", which will include avoidance of vigorous physical activity and alcoholic
beverages, and caffeinated beverages at least 24 hours preceding a Study Day. Usual
coffee and tea can be consumed up to noon time the day before and water encouraged
thereafter. Subjects will also be encouraged to get a usual night of sleep and maintain
usual dietary patterns, except for the guidance provided for limited polyphenol foods
and beverages.
2. Study Day Three days prior to each Study Day, subjects will be instructed NOT to consume
berry containing foods, or dark chocolate and record 3-consecutive days of food intake.
Subjects will be instructed to consume a usual dinner meal the night before the Study
Day and be required to repeat the same dinner and afternoon snacks the night before the
second, third and fourth Study Days.
On each Study Day, subjects will arrive at the clinic after fasting for 10-14 hours and in a
well-hydrated and well-rested state. If they are taking any medication(s) on regular basis,
they will be asked not to take the medication(s) at home and instead bring to the CNRC to be
taken in the presence of the study investigator so the medications(s) is taken at the same
time before each Study Day visit.
On the Study Day, after confirming compliance with the pre-study day procedures,
anthropometric measurements, vital signs (blood pressure, heart rate and ear temperature) and
capillary blood sampling (finger prick, confirmation of fasting state) will be taken. A
licensed healthcare professional (LHCP) will evaluate and place an intravenous catheter at
the antecubital site of subject's arm. An intravenous catheter is a thin flexible tube that
allows sampling of blood through one port throughout the Study Day. Once the catheter is
placed, a baseline blood sample will be taken (Time point t=0).
After completing a baseline blood draw, flow-mediated dilation (FMD) procedure will be
measured. Afterwards, subjects will receive a breakfast meal along with a drink beverage
(Control meal, Control meal +Active-Herbs/Spice mix, or + Italian herbs mix, or +Cinnamon).
The first blood sample will be collected at 0h, with FMD and additional blood samples
conducted/collected at 0.5h, 1 h, 2h, 4h, 5.5h, and 7h. After completion of the 7h blood
collection and FMD procedure, the catheter will be removed and subjects will be evaluated for
safety and/or discomfort/symptoms and they will be given a take-home snack. Subjects will be
asked to return the next morning for completion of 24 h procedures. All dinner and afternoon
snacks consumed on Study Day will be asked to be repeated for future Study Days.
Blood collection: There will be a total of 8 times of blood collection for each Study Day. At
the 0h, 2h, 4h, and 7h time points, blood will be collected a total of 64 milliliters (mL)
(16 mL per each time point) of blood. At the 0.5 h, 1 h, 5.5 h and 24h time points, a total
of 32 mL (8 mL per each time point) of blood will be collected. The total amount of blood
collection per test day 96 mL. . During the whole study, total amount of 384 mL of blood will
be collected which is less than the amount allowed for one time blood donation(550mL).
