Effect of Acute Protein Supplementation in Diabetic Patients

NCT06880614 | Completed

• 1 other identifier: LPK2203
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

  120 minutes

Secondary Outcomes (1)

• Blood insulin

  120 minutes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

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

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

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

Interventions

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

House Cricket; Placebo; Whey

Whey DIETARY_SUPPLEMENT

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

Whey

House cricket DIETARY_SUPPLEMENT

Supplemented with house cricket powder masked with chicken-flavored soup

House Cricket

Placebo DIETARY_SUPPLEMENT

Placebo consists of chicken-flavored soup without any supplement inside

Placebo

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Queen Elizabeth Hospital Kota Kinabalu

Kota Kinabalu, Sabah, 88200, Malaysia

Location

Related Publications (5)

• 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.

  PMID: 25343850 BACKGROUND

• 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.

  PMID: 36694303 BACKGROUND

• 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.

  PMID: 25005331 BACKGROUND

• 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.

  PMID: 35538144 BACKGROUND

• 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.

  PMID: 27157469 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test; Whey

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Ashril Yusof, PhD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, Cross over, Controlled Trial

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 17, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

MY (1)