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

December 26, 2021 updated by: B. Karthik Krishnan, Universiti Sains Malaysia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Hospital Universiti Sains Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kelulut Honey

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.
Dietary supplement: Kelulut Honey
The Substance being tested to be used as an alternative
Active Comparator: Carborie
Carborie Load which will be 100g of carbohydrate in 800 ML of water and 50g of carbohydrate in 400ml of water.
Dietary supplement: Carborie
The commercially available substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kelulut Honey Improves Insulin Resistance when used as carbo-loading preoperatively
Time Frame: 48 Hours
• To compare blood sugar levels between patients receiving Kelulut Honey and Carborie pre, intra, and post operatively.
48 Hours
Kelulut Honey would be completely cleared within 2 hours after consumption when used for carbo-loading preoperatively.
Time Frame: 2 hours
• To compare Residual Gastric Volume between patients receiving Kelulut Honey and Carborie preoperatively.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

September 25, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 26, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USMKK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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