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RecruitingNCT07321431Updated Jan 8, 2026

The Optimal Measurement Time for the New Gallbladder Function Assessment Method

An interventional study of oral administration of 2 fried eggs and oral protein bars + 50ml olive oil in Gallbladder; Functional Disturbance, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Recruiting at 5 sites in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gallbladder; Functional Disturbance

Keywords

  • Gallbladder Contractile Function
  • Ultrasound Examination
  • Olive oil
  • Protein Bar
  • Optimal time
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ultrasound assessment identifies people with normal biliary tract structure.

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    fried eggs

    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.

    Dietary Supplement: oral administration of 2 fried eggs

  • Active comparator
    protein bars

    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.

    Dietary Supplement: oral protein bars + 50ml olive oil

Interventions

  • Dietary supplementoral administration of 2 fried eggs

    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.

  • Dietary supplementoral protein bars + 50ml olive oil

    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.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: during procedure

  2. 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.

    Time frame: during procedure

Secondary outcomes

  1. 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.

    Time frame: 30 days

  2. Occurrence of Acute Pancreatitis

    Post-Intervention Pain and Amy 3 times as normal.

    Time frame: 30 days

  3. Occurrence of Gastrointestinal Bleeding Post-Intervention

    Black stool or decrease of hemoglobin.

    Time frame: 30 days

06

Study locations

5 of 5 sites recruiting
  • Hepatopancreatobiliary Surgery Institute of Gansu Province
    Lanzhou, Gansu 730000, China
    Recruiting
  • The First Hospital of Qinhuangdao
    Qinhuangdao, Hebei 066000, China
    Recruiting
  • The Jinqiu Hospital of Liaoning Province
    Shenyang, Liaoning 110016, China
    Recruiting
  • People's Hospital of Ningxia Hui Autonomous Region
    Yinchuan, Ningxia 750011, China
    Recruiting
  • Honghui Hospital of Xi'an Jiaotong University
    Xi’an, Shanxi 710054, China
    Recruiting
07

References and documents

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 35910468 ↗
  • Rehfeld 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07321431
Lead sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Responsible party
Wenbo Meng (Director of Surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province) — Principal investigator
First posted
Jan 7, 2026
Start date
Jan 7, 2026
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Jan 8, 2026

Study contacts

Wenbo Meng, M.D. Ph. D.
Contact
mengwb@lzu.edu.cn
13919177177
Long Deng, M.D.
Contact
ldyy_longdengld@lzu.edu.cn
13893192432
Wenbo Meng, M.D. Ph. D.
principal investigator · Hepatopancreatobiliary Surgery Institute of Gansu Province

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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