Gallbladder; Functional DisturbanceNCT07321431
The Optimal Measurement Time for the New Gallbladder Function Assessment Method
A study testing oral administration of 2 fried eggs and oral protein bars + 50ml olive oil in people with Gallbladder; Functional Disturbance, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gallbladder; Functional Disturbance
- What is being tested?
- oral administration of 2 fried eggs and oral protein bars + 50ml olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesChina
- Study dates
- 7 Jan 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ultrasound assessment identifies people with normal biliary tract structure.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
Wenbo Meng, MD,PhD, +8613919177177, mengwb@lzu.edu.cn
- Recruiting
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
Di Wu, M. D., +8615232304212, woody19840818@163.com
- Recruiting
The Jinqiu Hospital of Liaoning Province
Shenyang, Liaoning, 110016
Hao Xin, M. D., +8617740079110, 526375164@163.com
- Recruiting
Honghui Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710054
Yuanyuan Sun, M. D., +8615991695737, 415315217@qq.com
- Recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750011
Rui Wang, M. D., +8619995350582, 19995350582@163.com
About this study
Official title: The Optimal Measurement Time for the New Gallbladder Function Assessment Method: A Prospective, Multicenter, Double-Blind, Crossover 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.
Read the detailed description
This is a multicenter, prospective, randomized, single-blind, crossover study involving healthy individuals. This study will use a crossover trial method to compare oral fried eggs with oral protein bars + olive oil. Gallbladder ultrasound examinations will be performed at different time points to measure gallbladder volume, and the changes in gallbladder contraction rates at different time points under the two interventions will be calculated to determine the optimal time window for assessing gallbladder contraction function. On the other hand, the investigators will verify the stability of oral protein bars plus olive oil as a new method for measuring gallbladder contraction function, evaluate its reliability and reproducibility across different regions, hospitals, and populations, ensure its wide clinical application, and provide stronger support for the diagnosis and treatment of gallbladder-related diseases.
- Conditions
- Gallbladder; Functional Disturbance
- Being tested
- oral administration of 2 fried eggs, oral protein bars + 50ml olive oil
- Keywords
- Gallbladder Contractile Function, Ultrasound Examination, Olive oil, Protein Bar, Optimal time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral administration of 2 fried eggsDietary supplement
First, 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 oilDietary supplement
First, 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.
| Study group | Role | What they receive |
|---|---|---|
| fried eggs | Experimental | First, 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. Receives: Dietary Supplement: oral administration of 2 fried eggs |
| protein bars | Active comparator | First, 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. Receives: Dietary Supplement: oral protein bars + 50ml olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: during procedure
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.
Measured: during procedure
Secondary outcomes (3)
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.
Measured: 30 days
Occurrence of Acute Pancreatitis
Post-Intervention Pain and Amy 3 times as normal.
Measured: 30 days
Occurrence of Gastrointestinal Bleeding Post-Intervention
Black stool or decrease of hemoglobin.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start7 Jan 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gallbladder; Functional DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A two-period crossover design will be adopted, in which the two intervention methods will be randomly assigned.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D. Ph. D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321431
- Sponsor's protocol ID
- GB evaluating
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ai XN, Wang TF, Zhang Q, Ouyang CG, Wu ZY. Changes in Gallbladder Contractile Function and its Influencing Factors After Minimally Invasive Gallbladder-Preserving Surgery for Cholecystitis With Incarcerated Gallstones. Front Surg. 2022 Jul 14;9:926141. doi: 10.3389/fsurg.2022.926141. eCollection 2022.
PubMed 35910468Rehfeld JF. Clinical endocrinology and metabolism. Cholecystokinin. Best Pract Res Clin Endocrinol Metab. 2004 Dec;18(4):569-86. doi: 10.1016/j.beem.2004.07.002.
PubMed 15533776
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Measurement Time for the New Gallbladder Function Assessment Method: A Prospective, Multicenter, Double-Blind, Crossover Trial
- ClinicalTrials.gov ID
- NCT07321431
- Acronym / sponsor ID
- GB evaluating
- Conditions
- Gallbladder; Functional Disturbance
- Keywords
- Gallbladder Contractile Function, Ultrasound Examination, Olive oil, Protein Bar, Optimal time
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, prospective, randomized, single-blind, crossover study involving healthy individuals. This study will use a crossover trial method to compare oral fried eggs with oral protein bars + olive oil. Gallbladder ultrasound examinations will be performed at different time points to measure gallbladder volume, and the changes in gallbladder contraction rates at different time points under the two interventions will be calculated to determine the optimal time window for assessing gallbladder contraction function. On the other hand, the investigators will verify the stability of oral protein bars plus olive oil as a new method for measuring gallbladder contraction function, evaluate its reliability and reproducibility across different regions, hospitals, and populations, ensure its wide clinical application, and provide stronger support for the diagnosis and treatment of gallbladder-related diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-period crossover design will be adopted, in which the two intervention methods will be randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| fried eggs | Experimental | Dietary Supplement: oral administration of 2 fried eggsFirst, 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. |
| protein bars | Active comparator | Dietary Supplement: oral protein bars + 50ml olive oilFirst, 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ultrasound assessment identifies people with normal biliary tract structure.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral administration of 2 fried eggsFirst, 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. | Dietary supplement | fried eggs |
| oral protein bars + 50ml olive oilFirst, 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. | Dietary supplement | protein bars |
Primary outcome
Gallbladder Volume
Time frame: during procedure
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
Time frame: during procedure
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.
3 secondary outcomes
Presence of Abdominal
Time frame: 30 days
Occurrence of Acute Pancreatitis
Time frame: 30 days
Occurrence of Gastrointestinal Bleeding Post-Intervention
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 35910468Ai XN, Wang TF, Zhang Q, Ouyang CG, Wu ZY. Changes in Gallbladder Contractile Function and its Influencing Factors After Minimally Invasive Gallbladder-Preserving Surgery for Cholecystitis With Incarcerated Gallstones. Front Surg. 2022 Jul 14;9:926141. doi: 10.3389/fsurg.2022.926141. eCollection 2022.
- Background: PubMed 15533776Rehfeld JF. Clinical endocrinology and metabolism. Cholecystokinin. Best Pract Res Clin Endocrinol Metab. 2004 Dec;18(4):569-86. doi: 10.1016/j.beem.2004.07.002.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenbo Meng, M.D. Ph. D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral administration of 2 fried eggs and oral protein bars + 50ml olive oil in people with Gallbladder; Functional Disturbance, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbo Meng, M.D. Ph. D. (13919177177, mengwb@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gallbladder Volume (time frame: during procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07321431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.