NCT04438590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

June 16, 2020

Last Update Submit

December 26, 2021

Conditions

Insulin ResistanceERAS

Keywords

carbohydrate loadinghoneyinsulin resistancestingless beeERAS

Outcome Measures

Primary Outcomes (2)

  • 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.

    48 Hours

  • 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.

    2 hours

Study Arms (2)

Kelulut Honey

EXPERIMENTAL

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

Carborie

ACTIVE COMPARATOR

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

Dietary Supplement: Carborie

Interventions

Kelulut HoneyDIETARY_SUPPLEMENT

The Substance being tested to be used as an alternative

Kelulut Honey
CarborieDIETARY_SUPPLEMENT

The commercially available substance

Carborie

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (15)

  • Liz Goldenberg., Fasting versus Carb-Loading: What's the Evidence for Your Enhanced Recovery after Bariatric Surgery Program?, Bariatric Times. 2018;15(11):28-29

    BACKGROUND

  • Yagci G, Can MF, Ozturk E, Dag B, Ozgurtas T, Cosar A, Tufan T. Effects of preoperative carbohydrate loading on glucose metabolism and gastric contents in patients undergoing moderate surgery: a randomized, controlled trial. Nutrition. 2008 Mar;24(3):212-6. doi: 10.1016/j.nut.2007.11.003. Epub 2007 Dec 21.

    PMID: 18096368RESULT

  • Scott MJ, Fawcett WJ. Oral carbohydrate preload drink for major surgery - the first steps from famine to feast. Anaesthesia. 2014 Dec;69(12):1308-13. doi: 10.1111/anae.12921. Epub 2014 Oct 23. No abstract available.

    PMID: 25346490RESULT

  • Nakamura M, Uchida K, Akahane M, Watanabe Y, Ohtomo K, Yamada Y. The effects on gastric emptying and carbohydrate loading of an oral nutritional supplement and an oral rehydration solution: a crossover study with magnetic resonance imaging. Anesth Analg. 2014 Jun;118(6):1268-73. doi: 10.1213/ANE.0b013e3182a9956f.

    PMID: 24384864RESULT

  • Mustafa MZ, Yaacob NS, Sulaiman SA. Reinventing the Honey Industry: Opportunities of the Stingless Bee. Malays J Med Sci. 2018 Jul;25(4):1-5. doi: 10.21315/mjms2018.25.4.1. Epub 2018 Aug 30.

    PMID: 30914843RESULT

  • Maitra S, Kirtania J, Pal S, Bhattacharjee S, Layek A, Ray S. Intraoperative blood glucose levels in nondiabetic patients undergoing elective major surgery under general anaesthesia receiving different crystalloid solutions for maintenance fluid. Anesth Essays Res. 2013 May-Aug;7(2):183-8. doi: 10.4103/0259-1162.118953.

    PMID: 25885830RESULT

  • Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

    PMID: 28097305RESULT

  • Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.

    PMID: 19841366RESULT

  • Kratzing C. Pre-operative nutrition and carbohydrate loading. Proc Nutr Soc. 2011 Aug;70(3):311-5. doi: 10.1017/S0029665111000450.

    PMID: 21781358RESULT

  • Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.

    PMID: 23052794RESULT

  • Gianotti L, Biffi R, Sandini M, Marrelli D, Vignali A, Caccialanza R, Vigano J, Sabbatini A, Di Mare G, Alessiani M, Antomarchi F, Valsecchi MG, Bernasconi DP. Preoperative Oral Carbohydrate Load Versus Placebo in Major Elective Abdominal Surgery (PROCY): A Randomized, Placebo-controlled, Multicenter, Phase III Trial. Ann Surg. 2018 Apr;267(4):623-630. doi: 10.1097/SLA.0000000000002325.

    PMID: 28582271RESULT

  • Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614.

    PMID: 24417824RESULT

  • Zulkhairi Amin FA, Sabri S, Mohammad SM, Ismail M, Chan KW, Ismail N, Norhaizan ME, Zawawi N. Therapeutic Properties of Stingless Bee Honey in Comparison with European Bee Honey. Adv Pharmacol Sci. 2018 Dec 26;2018:6179596. doi: 10.1155/2018/6179596. eCollection 2018.

    PMID: 30687402RESULT

  • Sudiyatmo, et al., Effects of Preoperative Honey Drink on Gastric Content, Perioperative Discomfort and Insulin Resistance in Patients Undergoing Open Colorectal Surgery a Randomized, Controlled Trial. British Journal of Medicine & Medical Research, 14(7): 1-8, 2016.

    RESULT

  • Abdul JA, et al., Surgical Services In Malaysian Hospitals. National Healthcare Establishment & Workforce Statistics (NHEWS) 2011, NCRC/HSU/2013.1 C4:47-63, 2013

    RESULT

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 19, 2020

Study Start

October 1, 2020

Primary Completion

September 25, 2021

Study Completion

November 30, 2021

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations

MY(1)