About this trial
This is a multicenter, prospective, randomized, double-blind, crossover study involving healthy individuals, aiming to evaluate the stability of oral protein bars + olive oil as a new method for determining gallbladder contraction function and its optimal diagnostic time window.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ultrasound assessment identifies people with normal biliary tract structure.
Disqualifiers
History of Endoscopic Retrograde Cholangiopancreatography
Previous gallstone removal surgery with gallbladder preservation
Other biliary tract diseases and related surgical history
History of acute or chronic pancreatitis
Trial design
Crossover
Treatments tested in this trial
oral administration of 2 fried eggs
Dietary supplementFirst, the intervention of oral administration of 2 fried eggs is carried out. The size of the gallbladder is evaluated by ultrasound examination. The washout period is 1 week. After that, the first intervention process of group B is repeated.
oral protein bars + 50ml olive oil
Dietary supplementFirst, an intervention with oral protein bars + 50ml olive oil is conducted. The size of the gallbladder is evaluated through ultrasound examination. The washout period is 1 week. After that, the first intervention process of Group A is repeated.
Treatment groups
Trial outcomes
Primary outcomes
Gallbladder Volume
Formula for Ultrasound Measurement of Gallbladder Volume (L × W × D × 0.52). Measurements were taken every 20 minutes starting from 30 minutes after the intervention, with a total of 5 measurements (i.e., the gallbladder volume was measured at 30 minutes, 50 minutes, 70 minutes, 90 minutes, and 110 minutes respectively).
Gallbladder contraction rate
Subtract the volume of the gallbladder after intervention from the volume of the gallbladder on an empty stomach, then divide by the volume of the gallbladder on an empty stomach, and finally multiply by A-B/A%. The gallbladder contraction rate was calculated at all the above time points.
Secondary outcomes
Presence of Abdominal
Pain Post-Intervention If abdominal pain is present, it will be assessed using the Numerical Rating Scale (NRS) within 0-10, The higher the score, the more serious it is.
Occurrence of Acute Pancreatitis
Post-Intervention Pain and Amy 3 times as normal.
Occurrence of Gastrointestinal Bleeding Post-Intervention
Black stool or decrease of hemoglobin.
Sponsors and contacts
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