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Kelulut Honey as an Alternate Source of Carbo-Loading in Abdominal Surgery Involving the Digestive System (Kel-Load)

Primary Purpose

Insulin Resistance, ERAS

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Kelulut Honey
Carborie
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring carbohydrate loading, honey, insulin resistance, stingless bee, ERAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • Adult (Age ≥ 18)
  • Elective Surgery with Intraabdominal Involvement

Exclusion Criteria

  • Known Diabetics
  • Fasting Glucose Level > 7 mmol/L
  • ASA > 3
  • On Steroid Treatment
  • Recent Infection Past 3 Months
  • Preoperative Unintentional Weight Loss >10% of usual body weight within 6 months
  • Emergency Surgery
  • Minor (Age < 18)

Sites / Locations

  • Hospital Universiti Sains Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kelulut Honey

Carborie

Arm Description

Medical Grade Kelulut Honey which will be in 2 doses. The first would be diluted to 800 ml of water, and the second dose in 400ml of water.

Carborie Load which will be 100g of carbohydrate in 800 ML of water and 50g of carbohydrate in 400ml of water.

Outcomes

Primary Outcome Measures

Kelulut Honey Improves Insulin Resistance when used as carbo-loading preoperatively
• To compare blood sugar levels between patients receiving Kelulut Honey and Carborie pre, intra, and post operatively.
Kelulut Honey would be completely cleared within 2 hours after consumption when used for carbo-loading preoperatively.
• To compare Residual Gastric Volume between patients receiving Kelulut Honey and Carborie preoperatively.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
December 26, 2021
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04438590
Brief Title
Kelulut Honey as an Alternate Source of Carbo-Loading in Abdominal Surgery Involving the Digestive System
Acronym
Kel-Load
Official Title
The Use of Kelulut Honey for Carbohydrate-Loading in the Preoperative Period for Patients Undergoing Abdominal Surgery Involving the Digestive System as Part of Enhanced Recovery After Surgery as Opposed to VALENS® Carborie®Load
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 25, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to identify if Kelulut Honey can be a potential alternative for the use of preoperative carboloading instead of the commercially available product, Carborie.
Detailed Description
Enhanced Recovery After Surgery is a well-established, evidence based multimodal, multidisciplinary approach to the care of the surgical patient. The aim of the program, as per its nomenclature, is to establish a set of protocol to subject the surgical patient to in order to facilitate recovery, attenuate the metabolic responses from surgery, reduce complications and ultimately reduce length of stay as well as establish return of physiological function of the patient in an accelerated fashion. As mentioned, given that ERAS involves a multimodal, multidisciplinary approach, there are many aspects and guidelines as to the implementation of ERAS. One particular modern care change is conversion of the surgical dogma of overnight fasting to carbo-loading; whereby the patient is subjected to consume a carbohydrate rich drink the evening prior to surgery, and 2 hours prior to induction with anaesthesia. The doctrine of overnight fasting or rather 6-8 hours of fasting has long been the core principal for many anaesthesiologists and surgeons, given the rationale that this would reduce gastric acidity and volume, thereby reducing the risk of vomiting and gastric content aspiration. However, modern guidelines have shown that there are no evidence that shortened fast of 2-3 of oral fluids increase the risk of aspiration, regurgitation or increase morbidity as compared with fasting after midnight. The problem with fasting, is that it increases insulin resistance. In line with acute-phase response, and loss of lean body mass, this will attenuate the affects of prolonged fasting. So, in an insulin resistant state, cell glucose uptake is reduced, and therefore glycogen formation reduces, which means, the liver and muscle glycogen storage are depleted. Hyperglycaemia ensues, due to the enhanced endogenous glucose production. Glucose control needs to be adequate to avoid risk of surgical complication and mortality. The benefits of carbo-loading is well documented and the evidence is overwhelming. The evidence shows that oral ingestion of 50g of Carbohydrate has been shown to release Insulin similar to that of a mixed meal. The current guideline advocates 100g of carbohydrate consumed the evening prior to surgery and another 50g 2 hours before surgery. The first dose is consumed with 800 mL of water, and the subsequent dose with 400mL. Kelulut honey is a natural product, which contains sugar in the form of fructose and glucose produced by bees (Meliponini Sp). They have a rapid onset, as they are freely absorbed into the blood stream without requiring digestion. Honey also has a proven role in facilitating wound healing, and as an anti-inflammatory, and antibacterial agent. The aim of this study is to evaluate the use of honey as an alternative to maltodextrin extract for carbo-loading in patients undergoing elective gastrointestinal surgery (Upper GI and Lower GI) and its effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, ERAS
Keywords
carbohydrate loading, honey, insulin resistance, stingless bee, ERAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kelulut Honey
Arm Type
Experimental
Arm Description
Medical Grade Kelulut Honey which will be in 2 doses. The first would be diluted to 800 ml of water, and the second dose in 400ml of water.
Arm Title
Carborie
Arm Type
Active Comparator
Arm Description
Carborie Load which will be 100g of carbohydrate in 800 ML of water and 50g of carbohydrate in 400ml of water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Kelulut Honey
Intervention Description
The Substance being tested to be used as an alternative
Intervention Type
Dietary Supplement
Intervention Name(s)
Carborie
Intervention Description
The commercially available substance
Primary Outcome Measure Information:
Title
Kelulut Honey Improves Insulin Resistance when used as carbo-loading preoperatively
Description
• To compare blood sugar levels between patients receiving Kelulut Honey and Carborie pre, intra, and post operatively.
Time Frame
48 Hours
Title
Kelulut Honey would be completely cleared within 2 hours after consumption when used for carbo-loading preoperatively.
Description
• To compare Residual Gastric Volume between patients receiving Kelulut Honey and Carborie preoperatively.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Adult (Age ≥ 18) Elective Surgery with Intraabdominal Involvement Exclusion Criteria Known Diabetics Fasting Glucose Level > 7 mmol/L ASA > 3 On Steroid Treatment Recent Infection Past 3 Months Preoperative Unintentional Weight Loss >10% of usual body weight within 6 months Emergency Surgery Minor (Age < 18)
Facility Information:
Facility Name
Hospital Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
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Results Reference
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PubMed Identifier
18096368
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Citation
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Citation
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23052794
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Citation
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Kelulut Honey as an Alternate Source of Carbo-Loading in Abdominal Surgery Involving the Digestive System

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