Does oat-based milk take longer than fruit juices to empty from the stomach?
| ISRCTN | ISRCTN17147574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17147574 |
| Secondary identifying numbers | Okabereplika 1.1 |
- Submission date
- 02/06/2021
- Registration date
- 03/06/2021
- Last edited
- 27/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Many patients are subjected to unnecessarily long fasting periods before anesthesia and surgery. Current guidelines recommend a minimum of 6 hours fasting for solid and semi-solid food such as milk or yoghurt, which usually leads to fasting overnight even if the surgery is scheduled in the afternoon. Some paediatric centers have reduced the minimum fasting time to 4 hours for a "light breakfast" of a limited amount of food. However, there is not enough evidence to determine how much food is safe with a 4 hour limit.
The primary aim is to determine if 500 mls of either oat-based drink or fruit juice is emptied from the stomach after 4 hours. The secondary aim is to investigate if oat-based drink or fruit juice of the same caloric content have similar gastric emptying rates.
Who can participate?
Healthy adult volunteers
What does the study involve?
Participants will ingest 500 ml of one of 4 different fluids after an overnight fast. Changes in gastric cross-sectional area are monitored repeatedly during four hours using gastric ultrasound. The volunteers will repeat the procedure for all 4 fluids in a randomised order.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Uppsala University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2021 to March 2022
Who is funding the study?
Uppsala University (Sweden)
Who is the main contact?
Dr Peter Frykholm, peter.frykholm@surgsci.uu.se
Contact information
Scientific
Dept of Surgical Sciences
Uppsala University Hospital
Uppsala
75185
Sweden
 ORCID ID |
0000-0001-6402-136X |
|---|---|
| Phone | +46186171240 |
| peter.frykholm@surgsci.uu.se |
Study information
| Study design | Randomized cross-over single blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN17147574_PIS.pdf |
| Scientific title | Gastric emptying of non-clear fluids: a comparison of vegetable-based milk product with iso-calorically adjusted clear fluids |
| Study objectives | Gastric emptying is similar after ingestion of fluids of different composition but with the same volume and the same caloric content. |
| Ethics approval(s) | Approved 21/03/2021, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: #2021-00623 |
| Health condition(s) or problem(s) studied | Determination of the rate of gastric emptying of two different types of fluid in healthy volunteers |
| Intervention | 16 healthy volunteers will ingest 500 ml of one of 4 different fluids after an overnight fast. Changes in gastric cross-sectional area are monitored repeatedly for four hours using gastric ultrasound. The volunteers will repeat the procedure for all 4 fluids in a randomised order. The ultrasound operator is blinded to the type of fluid ingested. Randomisation in blocks of four using the website https://www.Randomize.org. Each subject picks a sealed envelope that includes the order in which he will take his drinks. The envelope is opened by a researcher not involved in the ultrasound exams that particular day. |
| Intervention type | Supplement |
| Primary outcome measure | Gastric antral surface area (cm2) Measurement method: the abdomen is scanned with a curvilinear probe, the antrum is identified in the same plane as either the aorta, the superior mesenteric artery or the lower vena cava. The image is frozen antd the cross-sectional area (CSA) is delineated using the ultrasound machine's internal software application. Measurements are taken at baseline (before ingestion of study drink), and up to 360 minutes after ingestion if needed, but until the antral CSA reaches baseline +/- 5%. |
| Secondary outcome measures | Gastric antral surface area (cm2) measured as above at baseline and 10, 20, 30, 40, 50, 60, 100, 140, 180, 210, 240, 270, 300, 330 minutes after ingestion |
| Overall study start date | 10/01/2021 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 8 males and 8 females |
| Total final enrolment | 16 |
| Key inclusion criteria | Healthy adults without ongoing medication or medical condition associated with delayed gastric emtpying |
| Key exclusion criteria | 1. Diabetes 2. Gastrointestinal motility disorder 3. Pregnancy beyond the 2nd trimester 4. Medications that delay gastric emptying 5. Previous abdominal surgery 6. Morbid obesity |
| Date of first enrolment | 03/06/2021 |
| Date of final enrolment | 03/01/2022 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Dept of Surgical Sciences
Uppsala
752 85
Sweden
Sponsor information
University/education
Dept of Surgical Sciences
Uppsala University Hospital
Uppsala
75185
Sweden
| Phone | +46186110000 |
|---|---|
| Per.Hellman@surgsci.uu.se | |
| Website | https://www.uu.se/en |
"ROR" |
https://ror.org/048a87296 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Uppsala University, UU_University, Uppsala Universitet, Sweden, UU
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | We plan to publish the study in a peer-reviewed anaesthesiology journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 08/07/2021 | No | Yes | ||
| Protocol file | 08/07/2021 | No | No | ||
| Results article | 25/11/2023 | 27/11/2023 | Yes | No |
Additional files
- ISRCTN17147574_PROTOCOL_no_date.pdf
- Uploaded 08/07/2021
- ISRCTN17147574_PIS.pdf
- Uploaded 08/07/2021
Editorial Notes
27/11/2023: Publication reference added.
08/12/2022: The intention to publish date was changed from 30/06/2022 to 01/04/2023.
04/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 03/01/2022.
2. The final enrolment number has been added.
08/07/2021: Uploaded protocol (not peer reviewed). The participant information sheet has been uploaded.
03/06/2021: Trial's existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)
