AbStats: Assessing Post-Prandial Intestinal Event Rates in Healthy Individuals
Condition: Post-prandial Intestinal Rates
Study type: Observational

Summary: 
      This study seeks to: Assess "normal" intestinal event rates for healthy subjects, to
      determine the effect of meal size on an individual's intestinal rate, and to determine
      whether there are differences between individuals in the fasting and post-prandial setting.

      The investigators hypothesize the following:

        1. Fasting intestinal rate will be consistently less than 14 events per minute, similar to
           previously documented bowel sound frequency.

        2. There will a uniform increase in intestinal rate in the immediate post-prandial setting.
           There will be direct correlation between maximal and average post-prandial intestinal
           rates and meal size. Likewise, meal size will correlate with time to baseline fasting
           intestinal rate.

        3. Males and those with lower body mass index (BMI) will experience higher maximal and
           average post-prandial intestinal rates and shorter time to baseline fasting levels
           compared to females and those with higher BMI, respectively.
    

Detailed description: 
      Participants will complete a baseline demographic and medical data sheet comprising of age,
      gender, race, ethnicity, height, weight, education, employment status, past medical history,
      and current prescription and over-the-counter medications. An AbStats device along with a log
      sheet will be provided to each subject, both of which will be returned upon completion of
      participation.

      Upon waking, prior to oral intake, participants will place the AbStats disposable sensor on
      their abdomen and secure it using adhesive tape. The sensor is connected to a monitor which
      records the sounds collected by the sensors and interprets them to create and intestinal rate
      reading, measured as acoustic events per minute. The device will display a numerical
      intestinal rate reading, measured as acoustic events per minute. The device will display a
      numerical intestinal rate that participants will record on their personal log sheet. The
      purpose of this value is to assess the intestinal rate during fasting.

      Participants will then eat a small standardized breakfast comprised of a thinkThin oatmeal
      single serve bowl, toasted English muffin with butter, and an 11oz iced coffee. No additions
      or substitutions are permitted in order to standardize the meal. The percent of food eaten
      will be recorded on the log sheet.

      Lunch on Day 1 will be a "small meal" consisting of half of a turkey and Swiss Corner Bakery
      sandwich, cup of fruit, and 12oz can of diet soda. It will be eaten four to five hours after
      breakfast. No snacks are permitted between breakfast and lunch. Again, a pre-meal intestinal
      rate reading will be obtained 30 minutes prior to eating lunch; participants will secure the
      device onto the abdomen multiple times in order to gather post-prandial data. The intestinal
      rate will be recorded on the log sheet. The subject will record intestinal rate every 30
      minutes for 5 hours after completion of the meal (e.g., lunch at 12 pm, then place sensors on
      abdomen for 10 minutes at 12:30 pm, 1:00 pm, 1:30 pm, 2:00 pm, 2:30 pm, 3:00 pm, 3:30 pm, 4:
      00 pm, 4:30 pm, and 5:00 pm). Afterwards, participants can eat freely once these data points
      have been obtained. Dinner will be a meal of their choosing.

      Day 2 of the study will be largely similar to Day 1: participants will measure fasting
      intestinal rate upon waking and will eat a standardized breakfast (see above). The main
      difference in Day 2 is that participants will eat a "large meal" for lunch consisting of a
      full turkey and Swiss Corner Bakery sandwich, cup of fruit, small bag of potato chips, small
      cookie, and a 12oz can of diet soda. The same pre- and post-lunch measurements notes above
      will be measured and recorded. By performing the above, investigators will assess preliminary
      intestinal rate measurements in the fasting state, after a small lunch (Day 1), and after a
      large lunch (Day 2).
    

Intervention name(s): Abdominal acoustic measurement
Intervention type(s): Other
Intervention description(s): On Day 1 participants will record their intestinal rate at baseline fasting, pre-"small meal," and upon completion of the meal. On Day 2 participants will record their intestinal rate at baseline fasting, pre-"large meal," and upon completion of meal.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects