ClinicalTrials.gg
CompletedNCT05342116Updated Apr 10, 2024

Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures

An interventional study of Nestle Preload and Water in Hunger, Depression and Anxiety, sponsored by Tan Tock Seng Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by Tan Tock Seng Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Apr 2019, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 34 studies in Depression with a site in Singapore — 14 open to participants now, 18 under way, none of them phase 3. Depression · Singapore.

Enrollment
5th of 25
300 · median 122
Started
2019
with 4 others
No phase
23 of 34
11 open now
Registered
16th of 34
by date

Among the 34 studies in Depression with a site in Singapore, this one is the 5th largest by enrollment of the 25 interventional ones that give a count, is one of 5 that started in 2019, is one of 23 with no phase, and was the 16th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

14 of the 34 studies in Depression with a site in Singapore are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in Singapore have not opened yet or have stopped. Only those recruiting at a site in Singapore →

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 21 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies in Depression with a site in Singapore, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Hunger
  • Depression
  • Anxiety
  • Vomiting
  • Abdominal Pain
  • Thirst
  • Fatigue
  • Lethargy
04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Planned for elective gastroscopy.
  • Able to communicate to give and complete the questionnaire
  • 21 to 80 year old
  • I-II

Exclusion criteria

Exclusion Criteria:

  • 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 or complete the questionnaire
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • No intervention
    Fasting Arm

    Patient will fast at least 6 hours prior to endoscopy

  • Active comparator
    Water Arm

    Patient will drink 400 ml of water 2 to 4 hours prior to endoscopy

    Other: Water

  • Experimental
    CHO Arm

    Patient will drink 400 ml of Preload 2 to 4 hours prior to endoscopy

    Other: Nestle Preload

Interventions

  • OtherNestle Preload

    1 sachet of Preload (50g) diluted with 400ml of water, to be consumed 2 to 4 hours prior to the endoscopy.

  • OtherWater

    400ml of water to be consumed 2 to 4 hours prior to the endoscopy.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Questionnaire to be completed 30 to 60 minutes before endoscopy.

Secondary outcomes

  1. 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.

    Time frame: Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.

  2. 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.

    Time frame: Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.

07

Study locations

1 site
  • Tan Tock Seng Hospital
    Singapore, 308433, Singapore
08

References and documents

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 21242424 ↗
  • Hausel 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 11682427 ↗
  • Practice 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 28045707 ↗
  • Brady 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 14584013 ↗
  • Nygren 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 ↗

Individual participant data

Plan to share: No — With the initial pilot study results, we intend to expand it to other endoscopic procedures.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Nov 2023, 55 months.

Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 55 months is above that.

Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2022
First posted
Apr 22, 2022
StartActual
Apr 4, 2019
Primary completionActual
Nov 30, 2023
CompletionActual
Nov 30, 2023
Last update
Apr 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05342116
Responsible party
Ng Wee Khoon (Consultant, Tan Tock Seng Hospital) — Principal investigator
First posted
Apr 22, 2022
Start date
Apr 4, 2019
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023
Last update
Apr 10, 2024

Study contacts

Doris Ng, MBBS
study director · Tan Tock Seng Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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