The Optimal Measurement Time for the New Gallbladder Function Assessment Method

NCT ID: NCT07321431

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-07

Study Completion Date

2026-12-20

Brief Summary

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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

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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

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Gallbladder; Functional Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A two-period crossover design will be adopted, in which the two intervention methods will be randomly assigned.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The PI, study biostatistician will be masked until database lock.

Study Groups

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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.

Group Type EXPERIMENTAL

oral administration of 2 fried eggs

Intervention Type DIETARY_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.

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.

Group Type ACTIVE_COMPARATOR

oral protein bars + 50ml olive oil

Intervention Type DIETARY_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.

Interventions

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oral 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.

Intervention Type DIETARY_SUPPLEMENT

oral 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Wenbo Meng

Director of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenbo Meng, M.D. Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

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Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Site Status RECRUITING

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Site Status RECRUITING

The Jinqiu Hospital of Liaoning Province

Shenyang, Liaoning, China

Site Status RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Site Status RECRUITING

Honghui Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenbo Meng, M.D. Ph. D.

Role: CONTACT

13919177177

Long Deng, M.D.

Role: CONTACT

13893192432

Facility Contacts

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Wenbo Meng, MD,PhD

Role: primary

+8613919177177

Di Wu, M. D.

Role: primary

+8615232304212

Hao Xin, M. D.

Role: primary

+8617740079110

Rui Wang, M. D.

Role: primary

+8619995350582

Yuanyuan Sun, M. D.

Role: primary

+8615991695737

References

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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.

Reference Type BACKGROUND
PMID: 35910468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15533776 (View on PubMed)

Other Identifiers

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GB evaluating

Identifier Type: -

Identifier Source: org_study_id

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