- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06880614
Effect of Acute Protein Supplementation in Diabetic Patients
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sabah
-
Kota Kinabalu, Sabah, Malaysia, 88200
- Queen Elizabeth Hospital Kota Kinabalu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
This arm will be given chicken-flavored soup without any supplements before conducting the oral glucose tolerance test
|
The participants are required to drink a glucose solution containing 75 g of glucose dissolved in 250 mL of water
Placebo consists of chicken-flavored soup without any supplement inside
|
|
Active Comparator: Whey
This arm will be given chicken-flavored soup containing whey isolate powder before conducting the oral glucose tolerance test
|
The participants are required to drink a glucose solution containing 75 g of glucose dissolved in 250 mL of water
Supplemented with whey protein isolate masked with a chicken-flavored soup
|
|
Experimental: House Cricket
This arm will be given chicken-flavored soup containing house cricket powder before conducting the oral glucose tolerance test
|
The participants are required to drink a glucose solution containing 75 g of glucose dissolved in 250 mL of water
Supplemented with house cricket powder masked with chicken-flavored soup
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood insulin
Time Frame: 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.
|
120 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashril Yusof, PhD, University of Malaya
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Food
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Beverages
- Dairy Products
- Milk
- Blood Chemical Analysis
- Clinical Chemistry Tests
- Diagnostic Techniques, Endocrine
- Glucose Tolerance Test
- Whey
Other Study ID Numbers
- LPK2203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.