Effect of Acute Protein Supplementation in Diabetic Patients

University of Malaya

Status: Not yet enrolling

Conditions: Diabetes Mellitus Type 2

Treatments: Dietary Supplement: Placebo; Dietary Supplement: House cricket; Dietary Supplement: Whey; Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)

Study type: Interventional

Funder types: Other

Identifiers

NCT06880614

LPK2203

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)

Dietary Supplement: Placebo

Whey

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)

Dietary Supplement: Whey

House Cricket

Experimental group

Description:

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

Treatment:

Diagnostic Test: Oral Glucose Tolerance test (75g 2-hour)

Dietary Supplement: House cricket