Effect of Acute Protein Supplementation in Diabetic Patients

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus Type 2

• Registration Number: NCT06880614
• Lead Sponsor: University of Malaya

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

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-14
• Study First Posted: 2025-03-17
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Study Start: 2025-05
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Blood glucose	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.

Secondary Outcome Measures

Name	Time	Method
Blood insulin	120 minutes	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.