Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05009420 |
| Other study ID # |
IRB-2021-108 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 19, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
February 2023 |
| Source |
Clinical Nutrition Research Center, Illinois Institute of Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary objectives are to
- Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado.
- Confirm no avocation b present in the plasma of individuals that avoided avocado intake
for 7 days.
- Determine the effect of an overnight fast on avocation b detection.
Description:
The proposed study will be conducted in humans according to Good Clinical Practice (GCP)
guidelines. All subjects will review and sign an Informed Consent Form approved by the
Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
SCREENING To learn more about the study and to pre-qualify, potential subjects can call the
CNRC or visit the website posted on recruitment flyers or from other recruitment materials.
If they call the CNRC, a staff member will provide a brief background on the study and ask a
series of questions from a screening questionnaire to see if they may be eligible to
participate. The same questionnaire is available on the website and can be filled out by
potential subjects online. The screening questionnaire includes self-reported information
about health status and lifestyle factors that can be used to determine if someone is not
eligible for the study (i.e.: has diabetes, cardiovascular disease, on interfering meds,
etc…).
Based on the results of the questionnaires, BMI calculation, and health evaluation, subjects
who meet the inclusion and exclusion criteria will be invited to participate in the study.
Eligible subjects will be trained on "how to prepare for study visit". This will include
instructions for avoiding avocados for at least 7 days prior to the study Visit, fasting
overnight (10-12 hours), avoidance of vigorous physical activity, alcoholic and caffeinated
beverage consumption for at least 24 hours preceding a study day, maintain regular sleep
pattern. If the subject did not get enough sleep during the night preceding a study day, the
investigators will reschedule their study day.
STUDY DAY:
Study Day visit will last about 1.5 hours with a 30 minutes follow-up visit 24 h after the
start of the study treatment.
On a Study Day visit, subjects will arrive at the clinic after fasting for at least 10 hours
and in a well-hydrated and well-rested state. Subjects will be inquired for compliance to
avocado-free food at least 7 days prior to study day and details of food intake in the
24-hour period prior to the visit to ensure consistency and compliance with the protocol
requirements. After confirming compliance with the [ protocol, anthropometric measurements,
vital signs (blood pressure, heart rate, and ear temperature) will be taken.
A finger prick for fasting blood glucose will be done to confirm the fasting status. A
licensed healthcare professional (LHCP) will draw a baseline blood sample using a butterfly
needle (Timepoint t=0). After completing a baseline blood draw, subjects will receive an
avocado and crackers to eat onsite. After consuming the avocado and crackers, subjects will
be given a take-home snack and be discharged and scheduled to come to CNR the following day
for an additional blood sample. The subject will be instructed to fast overnight (10-12
hours), and the blood collection time will be anchored to 24 h after the start of the study
treatment (avocado).
Blood collection: Blood will be collected a total of 2 times during the entire study period.
The investigators will collect 4 mL of blood each time. Over the course of the whole study,
the total amount of blood collected will be 8 mL, which is way less than what is allowed for
a one-time blood donation (~550 mL).
