Effect of Acute Protein Supplementation in Diabetic Patients

NCT ID: NCT06880614

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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

Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, Cross over, Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

This arm will be given chicken-flavored soup without any supplements before conducting the oral glucose tolerance test

Group Type PLACEBO_COMPARATOR

Oral Glucose Tolerance test (75g 2-hour)

Intervention Type DIAGNOSTIC_TEST

The participants are required to drink a glucose solution containing 75 g of glucose dissolved in 250 mL of water

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo consists of chicken-flavored soup without any supplement inside

Whey

This arm will be given chicken-flavored soup containing whey isolate powder before conducting the oral glucose tolerance test

Group Type ACTIVE_COMPARATOR

Oral Glucose Tolerance test (75g 2-hour)

Intervention Type DIAGNOSTIC_TEST

The participants are required to drink a glucose solution containing 75 g of glucose dissolved in 250 mL of water

Whey

Intervention Type DIETARY_SUPPLEMENT

Supplemented with whey protein isolate masked with a chicken-flavored soup

House Cricket

This arm will be given chicken-flavored soup containing house cricket powder before conducting the oral glucose tolerance test

Group Type EXPERIMENTAL

Oral Glucose Tolerance test (75g 2-hour)

Intervention Type DIAGNOSTIC_TEST

The participants are required to drink a glucose solution containing 75 g of glucose dissolved in 250 mL of water

House cricket

Intervention Type DIETARY_SUPPLEMENT

Supplemented with house cricket powder masked with chicken-flavored soup

Interventions

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Oral Glucose Tolerance test (75g 2-hour)

The participants are required to drink a glucose solution containing 75 g of glucose dissolved in 250 mL of water

Intervention Type DIAGNOSTIC_TEST

Whey

Supplemented with whey protein isolate masked with a chicken-flavored soup

Intervention Type DIETARY_SUPPLEMENT

House cricket

Supplemented with house cricket powder masked with chicken-flavored soup

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo consists of chicken-flavored soup without any supplement inside

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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%)
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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JERRY VANLIN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashril Yusof, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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Queen Elizabeth Hospital Kota Kinabalu

Kota Kinabalu, Sabah, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 25343850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36694303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25005331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35538144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27157469 (View on PubMed)

Other Identifiers

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LPK2203

Identifier Type: -

Identifier Source: org_study_id

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