The Optimal Measurement Time for the New Gallbladder Function Assessment Method

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.

Study Overview

• Status: Recruiting
• Conditions: Gallbladder; Functional Disturbance
• Intervention / Treatment: Dietary supplement: oral administration of 2 fried eggs; Dietary supplement: oral protein bars + 50ml olive oil

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Long Deng, M.D.; Phone Number: 13893192432; Email: ldyy_longdengld@lzu.edu.cn
• Study Contact Backup: Name: Wenbo Meng, M.D. Ph. D.; Phone Number: 13919177177; Email: mengwb@lzu.edu.cn

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Recruiting
      • Hepatopancreatobiliary Surgery Institute of Gansu Province
      • Contact: Wenbo Meng, MD,PhD; Phone Number: +8613919177177; Email: mengwb@lzu.edu.cn
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • Recruiting
      • The First Hospital of Qinhuangdao
      • Contact: Di Wu, M. D.; Phone Number: +8615232304212; Email: woody19840818@163.com
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • The Jinqiu Hospital of Liaoning Province
      • Contact: Hao Xin, M. D.; Phone Number: +8617740079110; Email: 526375164@163.com
  • Ningxia
    • Yinchuan, Ningxia, China, 750011
      • Recruiting
      • People's Hospital of Ningxia Hui Autonomous Region
      • Contact: Rui Wang, M. D.; Phone Number: +8619995350582; Email: 19995350582@163.com
  • Shanxi
    • Xi’an, Shanxi, China, 710054
      • Recruiting
      • Honghui Hospital of Xi'an Jiaotong University
      • Contact: Yuanyuan Sun, M. D.; Phone Number: +8615991695737; Email: 415315217@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
Occurrence of Acute Pancreatitis	Post-Intervention Pain and Amy 3 times as normal.	30 days
Occurrence of Gastrointestinal Bleeding Post-Intervention	Black stool or decrease of hemoglobin.	30 days

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Principal Investigator: Wenbo Meng, M.D. Ph. D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Olive oil; Ultrasound Examination; Gallbladder Contractile Function; Protein Bar; Optimal time
• Additional Relevant MeSH Terms: Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Oils; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fats, Unsaturated; Olive Oil
• Other Study ID Numbers: GB evaluating

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No