- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05009420
Validation of Avocatin b as a Biomarker of Food Intake (AVOC5)
Validation of Avocatin b as a Biomarker of Food Intake for Assessing the Acute Consumption of Avocado in Free-living Individuals
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.
Study Overview
Detailed 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60616
- Clinical Nutrition Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI 25-35
- Males/females
- 25-70 years of age
Exclusion Criteria:
- Does not eat avocados for a reason prohibiting them from being willing to eat 1 avocado
- Sensitive/allergic to avocados
- Allergies to latex or oral allergy syndrome
- Unstable medical conditions such as on dialysis for renal disease, cardiac, gastrointestinal, or hepatic disease, cancer (non-melanoma skin cancer >5 years ago acceptable, any cancer site >10yrs without recurrence).
- Pregnant, lactating, intention of pregnancy
- Lost or gained 15 lbs of body weight in last 2 months
- Following restricted or weight loss dietary patterns
- Elevated alcohol intake (7+ drinks/week females; 14+ drinks/week males)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Avocado
Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado.
|
avocado served with crackers as breakfast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in avocatin b (C17 lipid) concentration in plasma in healthy individuals, 24 hours after consumed 1 avocado.
Time Frame: baseline (time point 0) to 24 hours
|
fasting blood sample before eating a avocado compare with fasting blood sample 24 hours after consumed 1 avocado.
|
baseline (time point 0) to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
avocatin b (C17 lipid) concentration in plasma of individuals that avoided avocado intake for 7 days
Time Frame: Day-7-Day0
|
fasting blood sample after avoiding avocado for 7 days from healthy individuals
|
Day-7-Day0
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-2021-108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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