FastingNCT05573854
Residual Gastric Volume After the Ingestion of Supplements Containing Carbohydrates and Whey Protein
A study testing Gastric emptying after an oral supplement containing carbohydrates and whey protein and Overnight Fast in people with Fasting and Gastric Stasis, run by Federal University of Mato Grosso at 1 site in Brazil.
Trial summary
Oral supplements (OS) containing carbohydrates are being used 2h before anesthesia. The addition of a nitrogen source would improve these drinks designed for the abbreviation of preoperative fasting. The gastric emptying of an oral supplement containing whey protein in addition to carbohydrates was investigated. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting, Gastric Stasis, Perioperative Complication
- What is being tested?
- Gastric emptying after an oral supplement containing carbohydrates and whey protein and Overnight Fast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2022to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Young
- Healthy volunteers
Who cannot join
- Gastroparesis
- Any gastrointestinal condition,
- Any chronic disease,
- Alcohol or any drug ingestion the day before of the MRI study
- Not completion of the 3 phases of the study protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Universitário de Varzea Grande (UNIVAG)
Várzea Grande, Mato Grosso, 78.118-000
About this study
Official title: Residual Gastric Volume After the Ingestion of an Oral Supplement Containing Carbohydrates and Whey Protein. A Randomized Crossover Pilot Study
Oral supplements (OS) containing carbohydrates are being used 2h before anesthesia. The addition of a nitrogen source would improve these drinks designed for the abbreviation of preoperative fasting. The gastric emptying of an oral supplement containing whey protein in addition to carbohydrates was investigated. This is a randomized crossover study including six healthy young volunteers who were submitted to abdominal MRI in 3 phases: 1) after a overnight fast, 2) after drank 200 mL of an OS containing whey protein and carbohydrates (no lipids), and 3) 3h after ingestion of the mentioned OS. The gastric residual volume (GRV) will be evaluate by MRI. The overall findings would allow us to conclude whether the GRV, assessed by MRI, in healthy young volunteers after three hours of the ingestion of 200 ml of an oral supplement containing carbohydrates associated with whey proteins is similar to the GRV found after an overnight fast. This pilot study will add important information to allow future randomized trials including an arm with patients undergoing elective surgical procedures with a 3h fasting after the ingestion of an OS containing whey protein and carbohydrates.
Read the detailed description
One of most important prescription of enhanced recovery after surgery protocols is the reduction of preoperative fasting time in opposition to the traditional recommendation of overnight fast. This changing from prolonged fast to only 2-3h after the ingestion of 200-400 mL of carbohydrate (CHO)-enriched drinks in not only safe but recommended by various societies of anesthesia and nutrition. A long list of beneficial effects associated with the abbreviation of the preoperative fasting time with CHO beverages is reported ranging from alleviation of thirst, hunger and stress of the patient to metabolic benefits such as the improvement of insulin resistance. However, new formulas for preoperative beverages continue to evolve during the last years aiming to achieve better results. The addition of glutamine, anti-oxidants e recently whey protein to CHO-enriched formula has been tested and associated with a better reduction of insulin resistance, decrease of acute phase inflammatory response, and increasing production of glutathione. The effect of whey protein-enriched preoperative drinks on the postoperative functional capacity of patients are awaited. Nevertheless, only a few studies have tested the gastric emptying of drinks containing whey protein in addition to CHO Thus, the aim of this study is to investigate in healthy volunteers the gastric residual volume (GRV) 3h after ingesting a formula containing CHO and whey protein.
Methods This is an experimental pilot crossover clinical trial design.The data will be collected in three phases. Firstly, after a fasting period of eight hours, the participants attended the Radiology Service of the Hospital de Cancer, Cuiaba, Brazil to perform MRI images of the upper abdomen with the objective of measuring the fasting GRV (phase 1). In this phase, adequate stomach motility will be observed to exclude cases of possible gastroparesis that could interfere with gastric emptying and expected results. GRV (cmˆ3) will be measured in the fasting state as explained below. In phase 2, each participant while still inside the MRI exam room will ingest 200mL of the study drink described below. The individual will be immediately positioned in the supine position and another MRI scan will be carried out. In this second phase, GRV will be evaluated by tracking the same region of interest (ROI) in each slice, forming a volume by the sum of all ROIs. Finally, in phase 3 a third MRI scan of the upper abdomen to measure again the GRV as previously described will be done after a 3-hour pause.
Intervention oral supplement The oral supplement used as intervention for the study will be Nutren Fresh (Nestle, São Paulo, Brazil). This oral non-residual supplement (clear fluid) has 100% whey protein isolated from total proteins, with various vitamins (B1, B6, C, D, niacin and folic acid) with "lemon tea" flavor. In addition, the formula contains no lactose or lipids; is formulated with a volume of 200ml, with a caloric density of 1.28kcal/ml; protein: 10g in 200ml of product (100% whey protein isolate); and carbohydrate: 54g in 200ml of product (74% glucose syrup and 26% maltodextrin).
MRI Protocol All exams will be performed using the same MRI equipment which was a Magnetom Essenza 1.5T device; Siemens Healthcare, Brazil. Each volunteer will be placed in a supine position, with a body coil (Body Matrix) to capture the signal. Cross-sectional acquisitions with 40 slices (perpendicular to the longitudinal axis of the body) were performed in HASTE (echo-planar fast spin echo) sequences with a slice width of 4.0 mm at 3.0 mm intervals. This STEM sequence (TR [repetition time] 774 msec, TE [echo time] 92 msec) visualizes fluids with hypersignal as opposed to low signal from adjacent organs. Each acquisition of a set of images was performed during 15 seconds of apnea. The images will be captured by an industry technician with MRI experience and reviewed by a radiologist to confirm that the images covered the entire stomach. The GRV will be assessed by tracking the region of interest (ROI) in each slice, forming a volume by the sum of all ROIs. GRV measurements in cmˆ3 will be performed manually by tracing regions of interest on each slice using Osirix MD ANVISA v.12.0.3 software and summing the slices to determine total gastric volume and the results entered into an ExcelR data sheet for statistical analysis.
- Conditions
- Fasting, Gastric Stasis, Perioperative Complication, Safety Issues
- Being tested
- Gastric emptying after an oral supplement containing carbohydrates and whey protein, Overnight Fast
- Keywords
- Preoperative care, Preoperative fasting, Whey protein, Gastric residual volume, Oral nutritional supplement
- Medical subject headings
- Fasting, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric emptying after an oral supplement containing carbohydrates and whey proteinDietary supplement
Ingestion of an oral supplement containing carbohydrates and whey protein
Overnight FastDietary supplement
Residual Gastric Volume assessed by MRI after overnight fast (8h)
| Study group | Role | What they receive |
|---|---|---|
| Overnight Fast | Sham comparator | After an overnight fast period of eight hours, the 6 participants will attend the Radiology Service of the Hospital de Câncer, Cuiaba, Brazil to perform MRI images of the upper abdomen with the objective of measuring the fasting GRV. GRV will be evaluated by tracking the region of interest (ROI) in each slice, forming a volume by the sum of all ROIs (phase 1). Receives: Dietary Supplement: Overnight Fast |
| Oral Supplement | Active comparator | Each of the 6 participants while still inside the MRI exam room just after the MRI in fast condition, will ingest 200mL of the study oral supplement (OS). The individual will be immediately positioned in the supine position and another MRI scan will be carried out. In this second phase, GRV will be evaluated again as in phase 1 (phase 2). Receives: Dietary Supplement: Gastric emptying after an oral supplement containing carbohydrates and whey protein |
| 3h after ingestion | Active comparator | Finally, phase 3 will be performed after a 3-hour pause. All volunteers, while still in the Radiology Service and fasted after the ingestion of the OS described in phase 2, will be submitted to a third MRI scan of the upper abdomen to measure again the GRV as previously described. Receives: Dietary Supplement: Gastric emptying after an oral supplement containing carbohydrates and whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Residual Volume
Gastric residual Volume in cmˆ3 assessed by MRI 3h after ingestion of the OS
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Apr 2022
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The data will be collected in three phases. Firstly, after a fasting period of eight hours, the participants will attend the Radiology Service of the Hospital de Cancer, Cuiaba, Brazil to perform MRI images of the upper abdomen with the objective of measuring the fasting GRV (phase 1). In this phase, adequate stomach motility will be observed to exclude cases of possible gastroparesis. GRV (cmˆ3) will be measured in the fasting state by MRI tracking the region of interest (ROI) in each slice, forming a volume by the sum of all ROIs. In phase 2, each participant while still inside the MRI exam room will ingest 200 mL of the study drink described below. The individual will be immediately positioned in the supine position and another MRI scan will be carried out. Finally, phase 3 will be performed after a 3-hour pause and a third MRI scan will be done to measure again the GRV.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Mato Grosso
- Sponsor type
- University, hospital or other
- Collaborators
- Univag Centro Universitário
- Responsible party
- Principal investigator, José Eduardo de Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso
- Investigators
- Jose E Aguilar-Nascimento, MD, PhD, Principal investigator, Univag Centro Universitário
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573854
- Sponsor's protocol ID
- 51807421.6.0000.5692
- Status last verified
- Oct 2022
- First submitted
- 26 Jun 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share will be possible by request via email
Publications
de Aguilar-Nascimento JE, Caporossi C, Metelo JS, Tanajura GH, Canevari-de-Oliveira M, da Cunha Costa R. Safe intake of an oral supplement containing carbohydrates and whey protein shortly before sedation to gastroscopy; a double blind, randomized trial. Nutr Hosp. 2014 Mar 1;29(3):681-6. doi: 10.3305/nh.2014.29.3.7161.
PubMed 24559015Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.
PubMed 21668975Pimenta GP, de Aguilar-Nascimento JE. Prolonged preoperative fasting in elective surgical patients: why should we reduce it? Nutr Clin Pract. 2014 Feb;29(1):22-8. doi: 10.1177/0884533613514277. Epub 2013 Dec 11.
PubMed 24336400Nogueira PLB, da Silva MR, Dock-Nascimento DB, de Aguilar-Nascimento JE. Residual gastric volume after 3 h of the ingestion of an oral supplement containing carbohydrates alone or associated with whey protein: a randomized crossover pilot study. Perioper Med (Lond). 2022 Dec 27;11(1):56. doi: 10.1186/s13741-022-00289-6.
PubMed 36575506
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Gastric Volume After the Ingestion of an Oral Supplement Containing Carbohydrates and Whey Protein. A Randomized Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT05573854
- Acronym / sponsor ID
- 51807421.6.0000.5692
- Conditions
- Fasting, Gastric Stasis, Perioperative Complication, Safety Issues
- Keywords
- Preoperative care, Preoperative fasting, Whey protein, Gastric residual volume, Oral nutritional supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Federal University of Mato GrossoUniversity, hospital or other
- Collaborators
- Univag Centro Universitário
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral supplements (OS) containing carbohydrates are being used 2h before anesthesia. The addition of a nitrogen source would improve these drinks designed for the abbreviation of preoperative fasting. The gastric emptying of an oral supplement containing whey protein in addition to carbohydrates was investigated. This is a randomized crossover study including six healthy young volunteers who were submitted to abdominal MRI in 3 phases: 1) after a overnight fast, 2) after drank 200 mL of an OS containing whey protein and carbohydrates (no lipids), and 3) 3h after ingestion of the mentioned OS. The gastric residual volume (GRV) will be evaluate by MRI. The overall findings would allow us to conclude whether the GRV, assessed by MRI, in healthy young volunteers after three hours of the ingestion of 200 ml of an oral supplement containing carbohydrates associated with whey proteins is similar to the GRV found after an overnight fast. This pilot study will add important information to allow future randomized trials including an arm with patients undergoing elective surgical procedures with a 3h fasting after the ingestion of an OS containing whey protein and carbohydrates.
Detailed description
One of most important prescription of enhanced recovery after surgery protocols is the reduction of preoperative fasting time in opposition to the traditional recommendation of overnight fast. This changing from prolonged fast to only 2-3h after the ingestion of 200-400 mL of carbohydrate (CHO)-enriched drinks in not only safe but recommended by various societies of anesthesia and nutrition. A long list of beneficial effects associated with the abbreviation of the preoperative fasting time with CHO beverages is reported ranging from alleviation of thirst, hunger and stress of the patient to metabolic benefits such as the improvement of insulin resistance. However, new formulas for preoperative beverages continue to evolve during the last years aiming to achieve better results. The addition of glutamine, anti-oxidants e recently whey protein to CHO-enriched formula has been tested and associated with a better reduction of insulin resistance, decrease of acute phase inflammatory response, and increasing production of glutathione. The effect of whey protein-enriched preoperative drinks on the postoperative functional capacity of patients are awaited. Nevertheless, only a few studies have tested the gastric emptying of drinks containing whey protein in addition to CHO Thus, the aim of this study is to investigate in healthy volunteers the gastric residual volume (GRV) 3h after ingesting a formula containing CHO and whey protein.
Methods This is an experimental pilot crossover clinical trial design.The data will be collected in three phases. Firstly, after a fasting period of eight hours, the participants attended the Radiology Service of the Hospital de Cancer, Cuiaba, Brazil to perform MRI images of the upper abdomen with the objective of measuring the fasting GRV (phase 1). In this phase, adequate stomach motility will be observed to exclude cases of possible gastroparesis that could interfere with gastric emptying and expected results. GRV (cmˆ3) will be measured in the fasting state as explained below. In phase 2, each participant while still inside the MRI exam room will ingest 200mL of the study drink described below. The individual will be immediately positioned in the supine position and another MRI scan will be carried out. In this second phase, GRV will be evaluated by tracking the same region of interest (ROI) in each slice, forming a volume by the sum of all ROIs. Finally, in phase 3 a third MRI scan of the upper abdomen to measure again the GRV as previously described will be done after a 3-hour pause.
Intervention oral supplement The oral supplement used as intervention for the study will be Nutren Fresh (Nestle, São Paulo, Brazil). This oral non-residual supplement (clear fluid) has 100% whey protein isolated from total proteins, with various vitamins (B1, B6, C, D, niacin and folic acid) with "lemon tea" flavor. In addition, the formula contains no lactose or lipids; is formulated with a volume of 200ml, with a caloric density of 1.28kcal/ml; protein: 10g in 200ml of product (100% whey protein isolate); and carbohydrate: 54g in 200ml of product (74% glucose syrup and 26% maltodextrin).
MRI Protocol All exams will be performed using the same MRI equipment which was a Magnetom Essenza 1.5T device; Siemens Healthcare, Brazil. Each volunteer will be placed in a supine position, with a body coil (Body Matrix) to capture the signal. Cross-sectional acquisitions with 40 slices (perpendicular to the longitudinal axis of the body) were performed in HASTE (echo-planar fast spin echo) sequences with a slice width of 4.0 mm at 3.0 mm intervals. This STEM sequence (TR [repetition time] 774 msec, TE [echo time] 92 msec) visualizes fluids with hypersignal as opposed to low signal from adjacent organs. Each acquisition of a set of images was performed during 15 seconds of apnea. The images will be captured by an industry technician with MRI experience and reviewed by a radiologist to confirm that the images covered the entire stomach. The GRV will be assessed by tracking the region of interest (ROI) in each slice, forming a volume by the sum of all ROIs. GRV measurements in cmˆ3 will be performed manually by tracing regions of interest on each slice using Osirix MD ANVISA v.12.0.3 software and summing the slices to determine total gastric volume and the results entered into an ExcelR data sheet for statistical analysis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The data will be collected in three phases. Firstly, after a fasting period of eight hours, the participants will attend the Radiology Service of the Hospital de Cancer, Cuiaba, Brazil to perform MRI images of the upper abdomen with the objective of measuring the fasting GRV (phase 1). In this phase, adequate stomach motility will be observed to exclude cases of possible gastroparesis. GRV (cmˆ3) will be measured in the fasting state by MRI tracking the region of interest (ROI) in each slice, forming a volume by the sum of all ROIs. In phase 2, each participant while still inside the MRI exam room will ingest 200 mL of the study drink described below. The individual will be immediately positioned in the supine position and another MRI scan will be carried out. Finally, phase 3 will be performed after a 3-hour pause and a third MRI scan will be done to measure again the GRV.
| Arm | Type | Receives |
|---|---|---|
| Overnight Fast | Sham comparator | Dietary Supplement: Overnight FastAfter an overnight fast period of eight hours, the 6 participants will attend the Radiology Service of the Hospital de Câncer, Cuiaba, Brazil to perform MRI images of the upper abdomen with the objective of measuring the fasting GRV. GRV will be evaluated by tracking the region of interest (ROI) in each slice, forming a volume by the sum of all ROIs (phase 1). |
| Oral Supplement | Active comparator | Dietary Supplement: Gastric emptying after an oral supplement containing carbohydrates and whey proteinEach of the 6 participants while still inside the MRI exam room just after the MRI in fast condition, will ingest 200mL of the study oral supplement (OS). The individual will be immediately positioned in the supine position and another MRI scan will be carried out. In this second phase, GRV will be evaluated again as in phase 1 (phase 2). |
| 3h after ingestion | Active comparator | Dietary Supplement: Gastric emptying after an oral supplement containing carbohydrates and whey proteinFinally, phase 3 will be performed after a 3-hour pause. All volunteers, while still in the Radiology Service and fasted after the ingestion of the OS described in phase 2, will be submitted to a third MRI scan of the upper abdomen to measure again the GRV as previously described. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Young
- Healthy volunteers
Key exclusion criteria (5 listed)
- Gastroparesis
- Any gastrointestinal condition,
- Any chronic disease,
- Alcohol or any drug ingestion the day before of the MRI study
- Not completion of the 3 phases of the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric emptying after an oral supplement containing carbohydrates and whey proteinIngestion of an oral supplement containing carbohydrates and whey protein | Dietary supplement | 3h after ingestion, Oral Supplement |
| Overnight FastResidual Gastric Volume assessed by MRI after overnight fast (8h) | Dietary supplement | Overnight Fast |
Primary outcome
Gastric Residual Volume
Time frame: 3 hours
Gastric residual Volume in cmˆ3 assessed by MRI 3h after ingestion of the OS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 24559015de Aguilar-Nascimento JE, Caporossi C, Metelo JS, Tanajura GH, Canevari-de-Oliveira M, da Cunha Costa R. Safe intake of an oral supplement containing carbohydrates and whey protein shortly before sedation to gastroscopy; a double blind, randomized trial. Nutr Hosp. 2014 Mar 1;29(3):681-6. doi: 10.3305/nh.2014.29.3.7161.
- Background: PubMed 21668975Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.
- Background: PubMed 24336400Pimenta GP, de Aguilar-Nascimento JE. Prolonged preoperative fasting in elective surgical patients: why should we reduce it? Nutr Clin Pract. 2014 Feb;29(1):22-8. doi: 10.1177/0884533613514277. Epub 2013 Dec 11.
- Derived from this study: PubMed 36575506Nogueira PLB, da Silva MR, Dock-Nascimento DB, de Aguilar-Nascimento JE. Residual gastric volume after 3 h of the ingestion of an oral supplement containing carbohydrates alone or associated with whey protein: a randomized crossover pilot study. Perioper Med (Lond). 2022 Dec 27;11(1):56. doi: 10.1186/s13741-022-00289-6.
- Individual participant dataSharing planned: Yes. Share will be possible by request via email
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose E Aguilar-Nascimento, MD, PhD principal investigator
Univag Centro Universitário
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric emptying after an oral supplement containing carbohydrates and whey protein and Overnight Fast in people with Fasting and Gastric Stasis, run by Federal University of Mato Grosso at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Residual Volume (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573854, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.