This research study is being done to compare the effects of Aprepitant and placebo on fasting gastric volume, accommodation volume, satiation (fullness) and gastric emptying.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.
Subjects will receive one placebo tablet daily for 5 consecutive days.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Gastric Emptying Half-Time of Solids as Measured by Scintigraphy
The time for half of the ingested solids to leave the stomach.
Time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested
Satiation Expressed as Volume to Fullness
Subjects will do a satiation/nutrient drink test, consuming Ensure at a relatively constant rate of 30 ml/min. Subjects will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 3.
Time frame: Day 4, approximately 30 minutes after liquid meal
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
Subjects will arrive to the Clinical Research and Trials Unit (CRTU) fasting. A radioactive marker will be administered intravenously. After a 10-15 minute wait period a fasting scan will be acquired using a dual-head gamma camera.
Time frame: Day 5, approximately 15 minutes after radioactive marker is administered
Postprandial Gastric Volume as Measured by SPECT
At the completion of the fasting scan, the subject will consume 300 ml of Ensure followed by a postprandial scan using a dual-head gamma camera.
Time frame: Day 5, approximately 30 minutes after liquid meal
Accommodation Volume as Measured by SPECT
This variable is calculated as postprandial gastric volume minus fasting volume.
Time frame: Day 5, approximately 30 minutes after liquid meal
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours
On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.
Time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested
Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours
On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 4 hours.
Time frame: Day 3, approximately 4 hours after radiolabeled meal is ingested
Maximum Tolerated Volume on Satiation Test
On Day 4, subjects will do a satiation/nutrient drink test. Participants will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 5.
Time frame: Day 4, approximately 30 minutes after liquid meal
Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test
Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end.
Time frame: Day 4, approximately 30 minutes after liquid meal
Aggregate Symptoms Score
Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end. The aggregate symptoms score is calculated by adding the mean individual scores. The lowest possible score would be 0 (none) and the highest maximum score possible is 400 (worst ever).
Time frame: Day 4, approximately 1 hour after liquid meal
Gastric Volume Ratio
Postprandial/fasting gastric volume
Time frame: Day 5, approximately 1 hour after radioactive marker is administered
Absolute postprandial gastric volume
This is the total postprandial gastric volume
Time frame: Day 5, approximately 1 hour after radioactive marker is administered