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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbo Meng, M.D. Ph. D. | Contact | 13919177177 | mengwb@lzu.edu.cn | |
| Long Deng, M.D. | Contact | 13893192432 | ldyy_longdengld@lzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wenbo Meng, M.D. Ph. D. | Hepatopancreatobiliary Surgery Institute of Gansu Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatopancreatobiliary Surgery Institute of Gansu Province | Recruiting | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35910468 | Background | 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. | |
| 15533776 | Background |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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A two-period crossover design will be adopted, in which the two intervention methods will be randomly assigned.
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The PI, study biostatistician will be masked until database lock.
|
| 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. |
|
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 |
| The First Hospital of Qinhuangdao | Recruiting | Qinhuangdao | Hebei | 066000 | China |
|
| The Jinqiu Hospital of Liaoning Province | Recruiting | Shenyang | Liaoning | 110016 | China |
|
| People's Hospital of Ningxia Hui Autonomous Region | Recruiting | Yinchuan | Ningxia | 750011 | China |
|
| Honghui Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710054 | China |
|
| 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. |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |