Clinical trial NCT06880614: Effect of Acute Protein Supplementation in Diabetic Patients
Official title: Effect of House Cricket Preload on Glycemic Response in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 20
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Cross over, Controlled Trial
Primary purpose: PREVENTION

Brief summary: The goal of this trial is to test the effect of house cricket (Acheta domesticus) preload on glycemic response in diabetic patients. The main question\[s\] it aims to answer are: whether house cricket powder could lower blood glucose spike and stimulate higher insulin response. Participants will consume either house cricket powder, whey protein isolate or placebo which will be mixed with a chicken-flavored soup. Participants fingers will be pricked for up to 2 hours.

Researcher will compare house cricket powder with placebo to see if the glycemic response is better in house cricket supplemented group.

Researcher will compare house cricket powder with whey protein isolate to see if both supplement induce comparable glycemic response.

Detailed description: Participants blood will be collected at 8 time points:

Baseline 20 minutes after pre load 15 minutes after Oral Glucose Tolerance Test (OGTT) 30 minutes after OGTT 45 minutes after OGTT 60 minutes after OGTT 90 minutes after OGTT 120 minutes after OGTT

Eligibility criteria: Inclusion Criteria:

* Suffering from type 2 diabetes mellitus (HbA1c \> 6.5%)
* Consume metformin for at least 6 months

Exclusion Criteria:

* Consume other type of anti-diabetic drugs
* Presenting any food allergy
* Recent surgery or infections that may affect oral glucose tolerance test
* Consume other drugs that may affect oral glucose tolerance test
* Not consuming any anti-diabetic drugs
* Pre-diabetes (HbA1c 5.7 - 6.4%)

Primary outcomes:
measure: Blood glucose
timeFrame: 120 minutes
Secondary outcomes:
measure: Blood insulin
timeFrame: 120 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaya
name: Ashril Yusof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clifton PM, Galbraith C, Coles L. Effect of a low dose whey/guar preload on glycemic control in people with type 2 diabetes--a randomised controlled trial. Nutr J. 2014 Oct 25;13:103. doi: 10.1186/1475-2891-13-103.
citation: Oberoi A, Giezenaar C, Rigda RS, Horowitz M, Jones KL, Chapman I, Soenen S. Effects of co-ingesting glucose and whey protein on blood glucose, plasma insulin and glucagon concentrations, and gastric emptying, in older men with and without type 2 diabetes. Diabetes Obes Metab. 2023 May;25(5):1321-1330. doi: 10.1111/dom.14983. Epub 2023 Feb 22.
citation: Jakubowicz D, Froy O, Ahren B, Boaz M, Landau Z, Bar-Dayan Y, Ganz T, Barnea M, Wainstein J. Incretin, insulinotropic and glucose-lowering effects of whey protein pre-load in type 2 diabetes: a randomised clinical trial. Diabetologia. 2014 Sep;57(9):1807-11. doi: 10.1007/s00125-014-3305-x. Epub 2014 Jul 10.
citation: Dai J, Lov J, Martin-Arrowsmith PW, Gritsas A, Churchward-Venne TA. The acute effects of insect vs. beef-derived protein on postprandial plasma aminoacidemia, appetite hormones, appetite sensations, and energy intake in healthy young men. Eur J Clin Nutr. 2022 Nov;76(11):1548-1556. doi: 10.1038/s41430-022-01157-8. Epub 2022 May 10.
citation: Kashima H, Uemoto S, Eguchi K, Endo MY, Miura A, Kobayashi T, Fukuba Y. Effect of soy protein isolate preload on postprandial glycemic control in healthy humans. Nutrition. 2016 Sep;32(9):965-9. doi: 10.1016/j.nut.2016.02.014. Epub 2016 Mar 8.