HungerNCT05342116
Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures
A study testing Nestle Preload and Water in people with Hunger and Depression, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
The study is a randomised controlled trial that aims to evaluate whether carbohydrate loading pre-endoscopy can improve patients' overall satisfaction and is not associated with negative impact on endoscopic quality or increased complications. A questionnaire will be completed by participants prior to endoscopy. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hunger, Depression, Anxiety
- What is being tested?
- Nestle Preload and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Apr 2019to 30 Nov 2023
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planned for elective gastroscopy.
- Able to communicate to give informed consent and complete the questionnaire
- 21 to 80 year old
- ASA physical status I-II
Who cannot join
- Medications that might impair gastrointestinal motility
- Conditions that may impair gastrointestinal motility, gastroesophageal reflux, pregnancy
- Potential for difficult airway management.
- Diabetic patients.
- American Society of Anesthesiology (ASA) physical status III or more
- Unable to communicate to give informed consent or complete the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
The study is a randomised controlled trial that aims to evaluate whether carbohydrate loading pre-endoscopy can improve patients' overall satisfaction and is not associated with negative impact on endoscopic quality or increased complications. A questionnaire will be completed by participants prior to endoscopy.
Read the detailed description
Currently, the evidence of usage of CHO is mainly for pre-operative patients and has never been evaluated for use in patients before endoscopic procedures which would also require them to fast substantially. Using the same principles of perioperative care, the aim of this a pilot study is to evaluate if Preload usage prior to endoscopic procedures will minimise patient discomfort secondary to fasting with alleviation of preprocedural thirst, hunger and anxiety symptoms. As a result, it may also reduce the urge for patients to drink and ingest prior to endoscopy, which may translate to last minute cancellation of procedures and wastage of precious resources. We believe it will improve overall patient experience and compliance to preprocedural fasting, without significant risks for patients or affecting the quality of endoscopy.
- Conditions
- Hunger, Depression, Anxiety, Vomiting, Abdominal Pain, Thirst
- Being tested
- Nestle Preload, Water
- Medical subject headings
- Depression, Anxiety Disorders, Vomiting, Abdominal Pain, Fatigue, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestle PreloadOther
1 sachet of Preload (50g) diluted with 400ml of water, to be consumed 2 to 4 hours prior to the endoscopy.
WaterOther
400ml of water to be consumed 2 to 4 hours prior to the endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Fasting Arm | No intervention | Patient will fast at least 6 hours prior to endoscopy |
| Water Arm | Active comparator | Patient will drink 400 ml of water 2 to 4 hours prior to endoscopy Receives: Other: Water |
| CHO Arm | Experimental | Patient will drink 400 ml of Preload 2 to 4 hours prior to endoscopy Receives: Other: Nestle Preload |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction.
To evaluate if Carbohydrate rich drink pre-endoscopy helps to reduce discomfort experienced by patients during fasting, with lesser thirst, hunger, pain and anxiety, resulting in better overall satisfaction for endoscopic procedures.
Participants will be asked to complete a Satisfaction Questionnaire prior to the endoscopy.
Measured: Questionnaire to be completed 30 to 60 minutes before endoscopy.
Secondary outcomes (2)
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients
Most endoscopy centres require patients to fast for 6 to 8 hours prior to endoscopy (fasting arm) or may allow clear fluids up till 2 hours prior to endoscopy (water arm). We aim to evaluate if Carbohydrate rich drink (CHO) has the same safety profile (in terms of risk of aspiration pneumonia and patient discomfort), compared to the conventional fasting arm and water arm.
Endoscopist performing the gastroscopy will complete an Endoscopist Questionnaire, which will record if there were any periprocedural complications.
Measured: Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation
Most endoscopy centres require patients to fast for 6 to 8 hours prior to endoscopy (fasting arm) or may allow clear fluids up till 2 hours prior to endoscopy (water arm). We aim to evaluate if Carbohydrate rich drink (CHO) affects the quality of gastric preparation (in terms of good endoscopic views during gastroscopy), compared to the conventional fasting arm and water arm.
Endoscopist performing the gastroscopy will complete an Endoscopist Questionnaire, which will record if there were good endoscopic views during the gastroscopy.
Measured: Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start4 Apr 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HungerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled trial with 3 arms: (1) Fasting 6 hours prior to endoscopy, (2) Allow up to 400ml of water up to 2 hours before endoscopy, (3) Carbohydrate loading with Preload 400ml at least 2-4 hours before endoscopy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ng Wee Khoon, Tan Tock Seng Hospital
- Investigators
- Doris Ng, MBBS, Study director, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342116
- Sponsor's protocol ID
- 2017/00872
- Other IDs
- 2017
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: With the initial pilot study results, we intend to expand it to other endoscopic procedures.
Publications
Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
PubMed 21242424Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.
PubMed 11682427Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. doi: 10.1002/14651858.CD004423.
PubMed 14584013Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.
PubMed 8526579
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures
- ClinicalTrials.gov ID
- NCT05342116
- Acronym / sponsor ID
- 2017/00872
- Conditions
- Hunger, Depression, Anxiety, Vomiting, Abdominal Pain, Thirst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 22 Apr 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.
The study is a randomised controlled trial that aims to evaluate whether carbohydrate loading pre-endoscopy can improve patients' overall satisfaction and is not associated with negative impact on endoscopic quality or increased complications. A questionnaire will be completed by participants prior to endoscopy.
Detailed description
Currently, the evidence of usage of CHO is mainly for pre-operative patients and has never been evaluated for use in patients before endoscopic procedures which would also require them to fast substantially. Using the same principles of perioperative care, the aim of this a pilot study is to evaluate if Preload usage prior to endoscopic procedures will minimise patient discomfort secondary to fasting with alleviation of preprocedural thirst, hunger and anxiety symptoms. As a result, it may also reduce the urge for patients to drink and ingest prior to endoscopy, which may translate to last minute cancellation of procedures and wastage of precious resources. We believe it will improve overall patient experience and compliance to preprocedural fasting, without significant risks for patients or affecting the quality of endoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomised controlled trial with 3 arms: (1) Fasting 6 hours prior to endoscopy, (2) Allow up to 400ml of water up to 2 hours before endoscopy, (3) Carbohydrate loading with Preload 400ml at least 2-4 hours before endoscopy.
| Arm | Type | Receives |
|---|---|---|
| Fasting Arm | No intervention | –Patient will fast at least 6 hours prior to endoscopy |
| Water Arm | Active comparator | Other: WaterPatient will drink 400 ml of water 2 to 4 hours prior to endoscopy |
| CHO Arm | Experimental | Other: Nestle PreloadPatient will drink 400 ml of Preload 2 to 4 hours prior to endoscopy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned for elective gastroscopy.
- Able to communicate to give informed consent and complete the questionnaire
- 21 to 80 year old
- ASA physical status I-II
Key exclusion criteria (6 listed)
- Medications that might impair gastrointestinal motility
- Conditions that may impair gastrointestinal motility, gastroesophageal reflux, pregnancy
- Potential for difficult airway management.
- Diabetic patients.
- American Society of Anesthesiology (ASA) physical status III or more
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 |
|---|---|---|
| Nestle Preload1 sachet of Preload (50g) diluted with 400ml of water, to be consumed 2 to 4 hours prior to the endoscopy. | Other | CHO Arm |
| Water400ml of water to be consumed 2 to 4 hours prior to the endoscopy. | Other | Water Arm |
Primary outcome
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction.
Time frame: Questionnaire to be completed 30 to 60 minutes before endoscopy.
To evaluate if Carbohydrate rich drink pre-endoscopy helps to reduce discomfort experienced by patients during fasting, with lesser thirst, hunger, pain and anxiety, resulting in better overall satisfaction for endoscopic procedures. Participants will be asked to complete a Satisfaction Questionnaire prior to the endoscopy.
2 secondary outcomes
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients
Time frame: Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation
Time frame: Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.
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 Apr 2024.
- Background: PubMed 21242424Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
- Background: PubMed 11682427Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.
- Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Background: PubMed 14584013Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. doi: 10.1002/14651858.CD004423.
- Background: PubMed 8526579Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.
- Individual participant dataSharing planned: No. With the initial pilot study results, we intend to expand it to other endoscopic procedures.
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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.
Doris Ng, MBBS study director
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nestle Preload and Water in people with Hunger and Depression, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 4 inclusion and 6 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 Apr 2024. 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 Singapore. 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. 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?
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction. (time frame: Questionnaire to be completed 30 to 60 minutes before endoscopy.). 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 NCT05342116, which also lists 5 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 Apr 2024.