Validation of Avocatin b as a Biomarker of Food Intake
Condition: Healthy
Study type: Interventional

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.
    

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).
    

Intervention name(s): Avocado
Intervention type(s): Other
Intervention description(s): avocado served with crackers as breakfast
Intervention model: Single Group Assignment
Intervention model description: Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado
Masking: None (Open Label)
Primary purpose: Other
Keywords: avocado