The Optimal Measurement Time for the New Gallbladder Function Assessment Method

NCT07321431 | Recruiting

• 1 other identifier: GB evaluating
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Gallbladder; Functional Disturbance

Keywords

Gallbladder Contractile Function; Ultrasound Examination; Olive oil; Protein Bar; Optimal time

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  during procedure

Secondary Outcomes (3)

• Presence of Abdominal

  30 days

• Occurrence of Acute Pancreatitis

  30 days

• Occurrence of Gastrointestinal Bleeding Post-Intervention

  30 days

Study Arms (2)

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.

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.

Dietary Supplement: oral protein bars + 50ml olive oil

Interventions

oral administration of 2 fried eggs 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.

fried eggs

oral protein bars + 50ml olive oil 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.

protein bars

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ultrasound assessment identifies people with normal biliary tract structure.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (5)

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

Related Publications (2)

• 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.

  PMID: 35910468 BACKGROUND

• 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.

  PMID: 15533776 BACKGROUND

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Wenbo Meng, M.D. Ph. D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbo Meng, M.D. Ph. D.

CONTACT

13919177177; mengwb@lzu.edu.cn

Long Deng, M.D.

CONTACT

13893192432; ldyy_longdengld@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI, study biostatistician will be masked until database lock.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgery

Model Details: A two-period crossover design will be adopted, in which the two intervention methods will be randomly assigned.

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: January 7, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)