Diabetes Mellitus Type 2NCT06880614
Effect of Acute Protein Supplementation in Diabetic Patients
A study testing Oral Glucose Tolerance test (75g 2-hour), Whey and House cricket in people with Diabetes Mellitus Type 2, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Oral Glucose Tolerance test (75g 2-hour), Whey and House cricket
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suffering from type 2 diabetes mellitus (HbA1c > 6.5%)
- Consume metformin for at least 6 months
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Queen Elizabeth Hospital Kota Kinabalu
Kota Kinabalu, Sabah, 88200
About this study
Official title: Effect of House Cricket Preload on Glycemic Response in Type 2 Diabetes Patients
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.
Read the 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
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Oral Glucose Tolerance test (75g 2-hour), Whey, House cricket, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance test (75g 2-hour)Diagnostic test
The participants are required to drink a glucose solution containing 75 g of glucose dissolved in 250 mL of water
WheyDietary supplement
Supplemented with whey protein isolate masked with a chicken-flavored soup
House cricketDietary supplement
Supplemented with house cricket powder masked with chicken-flavored soup
PlaceboDietary supplement
Placebo consists of chicken-flavored soup without any supplement inside
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This arm will be given chicken-flavored soup without any supplements before conducting the oral glucose tolerance test Receives: Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour); Dietary Supplement: Placebo |
| Whey | Active comparator | This arm will be given chicken-flavored soup containing whey isolate powder before conducting the oral glucose tolerance test Receives: Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour); Dietary Supplement: Whey |
| House Cricket | Experimental | This arm will be given chicken-flavored soup containing house cricket powder before conducting the oral glucose tolerance test Receives: Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour); Dietary Supplement: House cricket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Blood glucose concentration measured using glucometer. Participants fingers are pricked and using capillary tube, a drop of the blood is dripped in a test strip before inserted to a glucometer.
Measured: 120 minutes
Secondary outcomes (1)
Blood insulin
Blood sample is collected through a finger prick. The blood will be centrifuged to obtain the serum. Insulin serum concentration is then measured by using ELISA kits. The blood sample are treated following the kit guideline, and the insulin concentration are measured by comparing the light absorbance against a prepared standard.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jun 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Cross over, Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JERRY VANLIN, University of Malaya
- Investigators
- Ashril Yusof, PhD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880614
- Sponsor's protocol ID
- LPK2203
- Status last verified
- Dec 2025
- First submitted
- 14 Mar 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25343850Oberoi 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.
PubMed 36694303Jakubowicz 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.
PubMed 25005331Dai 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.
PubMed 35538144Kashima 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.
PubMed 27157469
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of House Cricket Preload on Glycemic Response in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT06880614
- Acronym / sponsor ID
- LPK2203
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, Cross over, Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour), Dietary Supplement: PlaceboThis arm will be given chicken-flavored soup without any supplements before conducting the oral glucose tolerance test |
| Whey | Active comparator | Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour), Dietary Supplement: WheyThis arm will be given chicken-flavored soup containing whey isolate powder before conducting the oral glucose tolerance test |
| House Cricket | Experimental | Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour), Dietary Supplement: House cricketThis arm will be given chicken-flavored soup containing house cricket powder before conducting the oral glucose tolerance test |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Suffering from type 2 diabetes mellitus (HbA1c > 6.5%)
- Consume metformin for at least 6 months
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | House Cricket, Placebo, Whey |
| WheySupplemented with whey protein isolate masked with a chicken-flavored soup | Dietary supplement | Whey |
| House cricketSupplemented with house cricket powder masked with chicken-flavored soup | Dietary supplement | House Cricket |
| PlaceboPlacebo consists of chicken-flavored soup without any supplement inside | Dietary supplement | Placebo |
Primary outcome
Blood glucose
Time frame: 120 minutes
Blood glucose concentration measured using glucometer. Participants fingers are pricked and using capillary tube, a drop of the blood is dripped in a test strip before inserted to a glucometer.
1 secondary outcome
Blood insulin
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 25343850Clifton 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.
- Background: PubMed 36694303Oberoi 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.
- Background: PubMed 25005331Jakubowicz 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.
- Background: PubMed 35538144Dai 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.
- Background: PubMed 27157469Kashima 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashril Yusof, PhD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance test (75g 2-hour), Whey and House cricket in people with Diabetes Mellitus Type 2, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06880614, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.