Best time to measure gallbladder squeezing after a test meal
The Optimal Measurement Time for the New Gallbladder Function Assessment Method: A Prospective, Multicenter, Double-Blind, Crossover Trial
NA · Hepatopancreatobiliary Surgery Institute of Gansu Province · NCT07321431
We will try whether a protein bar plus olive oil or two fried eggs makes the gallbladder contract more clearly on ultrasound in healthy adults and find the best time after eating to measure it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hepatopancreatobiliary Surgery Institute of Gansu Province (other) |
| Locations | 5 sites (Lanzhou, Gansu and 4 other locations) |
| Trial ID | NCT07321431 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, single-blind crossover trial in healthy volunteers comparing two oral test meals: two fried eggs versus a protein bar plus 50 ml olive oil. Participants will receive both interventions in separate visits while gallbladder ultrasound scans are performed at multiple time points to measure volume and calculate contraction rates. The study will compare the timing and magnitude of contraction between the two meals to determine the optimal diagnostic time window. Investigators will also examine the stability, reliability, and reproducibility of the protein bar plus olive oil protocol across the participating centers.
Who should consider this trial
Good fit: Healthy adults with normal biliary tract structure on ultrasound, no relevant surgical or biliary disease history, not pregnant or breastfeeding, and without allergy to the test foods are ideal candidates.
Not a fit: People with gallstones, prior biliary surgery, abnormal gallbladder structure, active biliary or severe systemic disease, pregnancy, breastfeeding, or food allergies would not be appropriate and are unlikely to benefit.
Why it matters
Potential benefit: If successful, a standardized protein bar plus olive oil test could make ultrasound measurement of gallbladder contraction faster and more reproducible across hospitals.
How similar studies have performed: Fatty-meal stimulation with ultrasound or nuclear HIDA testing is an established way to measure gallbladder function, but using a protein bar plus olive oil is a newer variation with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ultrasound assessment identifies people with normal biliary tract structure. Exclusion Criteria: * 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 * History of gastrointestinal surgery * Gastrointestinal obstruction * Dysfunction of the sphincter of Oddi * Gallbladder neck polyps * Abnormal gallbladder structure * Gallbladder mass * Biliary infection or stones * Congenital biliary abnormalities * Biliary injury or surgery * Biliary tumors * Gastrointestinal bleeding, liver cirrhosis, or other malignant diseases * Significant arrhythmia, bradycardia, or atrioventricular block * Severe hypertension, liver or kidney insufficiency * Immune, endocrine, hematological, or mental disorders * Severe cerebrovascular disease * Allergy to relevant foods * Pregnant or breastfeeding women * Unwillingness or inability to consent to participation
Where this trial is running
Lanzhou, Gansu and 4 other locations
- Hepatopancreatobiliary Surgery Institute of Gansu Province — Lanzhou, Gansu, China (RECRUITING)
- The First Hospital of Qinhuangdao — Qinhuangdao, Hebei, China (RECRUITING)
- The Jinqiu Hospital of Liaoning Province — Shenyang, Liaoning, China (RECRUITING)
- People's Hospital of Ningxia Hui Autonomous Region — Yinchuan, Ningxia, China (RECRUITING)
- Honghui Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (RECRUITING)
Study contacts
- Principal investigator: Wenbo Meng, M.D. Ph. D. — Hepatopancreatobiliary Surgery Institute of Gansu Province
- Study coordinator: Wenbo Meng, M.D. Ph. D.
- Email: mengwb@lzu.edu.cn
- Phone: 13919177177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gallbladder, Functional Disturbance, Gallbladder Contractile Function, Ultrasound Examination, Olive oil, Protein Bar, Optimal time