Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Carbohydrate Loading on Gastric Residual Volume and Hunger Score

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948594
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Bee Chen Lua, Universiti Sains Malaysia

Brief Summary:

This study conducted is to assess effect of carbohydrate loading (maltodextrin with whey protein) to gastric volume 2 hours after ingestion via aspiration while doing OGDS (direct visualisation) and patient's wellbeing (hunger, thirst, weakness, tiredness, anxiety) for all patient planned for OGDS.

hypothesis H1: There is significant association between carbohydrate loading with residual gastric volume and subject's wellbeing H0: there is no significant association between carbohydrate loading with gastric residual volume and subject's wellbeing


Condition or disease Intervention/treatment Phase
Gastric Residual Volume Dietary Supplement: resource Other: plain water Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are randomised into 2 group: group A with 250cc plain water and group B with 1 packet resource(237ml)
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Allocation sequence is according computer generated random number list, it was prepared by an investigator with no clinical involvement in the trial. Allocation sequence was concealed from researcher enrolling and assessing participants. Allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and I/C of the participant will be written on a book together with the series number on envelopes. The details in the book will be kept confidentially. After enrolled subject complete all baseline assessment, corresponding envelope will be enclosed by staff (who not involve in study) who prepare the drink. The staff need to ensure that the envelop still sealed when receive it. The staff will prepare the drink into identical container according to the assignment.
Primary Purpose: Treatment
Official Title: The Effect of Carbohydrate Loading on Gastric Residual Volume and Hunger Score: A Single Blind, Randomised Controlled Trial Study
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Placebo Comparator: plain water
subject drink 250cc plain water
Other: plain water
250ml plain water

Active Comparator: resource
subject drink 1 packet resource(237ml)
Dietary Supplement: resource
1 packet resource(237ml), 1.05kcal/ml, 53.6g carbohydrate and 9g protein




Primary Outcome Measures :
  1. gastric residual volume [ Time Frame: 2 hours after plain water or carbohydrate loading ]
    Amount of gastric residual volume (ml) that has been aspirated via OGDS 2 hours after plain water or carbohydrate loading group


Secondary Outcome Measures :
  1. patient's wellbeing [ Time Frame: baseline (before drink) and 120minutes after drinking ]
    Subject's wellbeing is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, thirst, anxiety, tiredness and weakness. Each scale consisted of ungraded, horizontal lines (with length of 100mm) anchored at two ends. The left end of the scale represented "not at all" which score: 0 and the right end represented and "the most imaginable" which score: 100. Subject need to mark X somewhere along the horizontal line given before drink and before OGDS procedure. Score of each parameter will be reported as mm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Patient more than 18 years old

Exclusion Criteria:

  • History of upper gastrointestinal surgery
  • Intestinal obstruction
  • Patient with vomiting
  • Mentally disable or who cannot give an informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948594


Contacts
Layout table for location contacts
Contact: Bee Chen Lua, M.D. +60127107200 beechen0806@outlook.com
Contact: Pak Kai Wong, M.Med Surgery +60143339628 michaelpkwong@usm.my

Sponsors and Collaborators
Universiti Sains Malaysia
Investigators
Layout table for investigator information
Principal Investigator: Bee Chen Lua, M.D. USM surgery
  Study Documents (Full-Text)

Documents provided by Bee Chen Lua, Universiti Sains Malaysia:
Additional Information:
Publications of Results:

Layout table for additonal information
Responsible Party: Bee Chen Lua, principal investigator, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT03948594    
Other Study ID Numbers: USM/JEPeM/19010082
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bee Chen Lua, Universiti Sains Malaysia:
resource
gastric residual volume
hunger score