Food Modification to Alter Glycaemia and Insulinaemia

Study Overview
=================
Brief Summary
-----------------
The study specifically aims to determine glycemic and insulinemic response of added low GI ingredients, beta-glucan, resistant starch and isomaltulose to foods.

Detailed Description
-----------------
There will be a total of 9 test sessions and each session will last up to 3 hours. At each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations. Subject will be served the test food and to consume within15 minutes. Following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.

Official Title
-----------------
Food Modification to Alter Glycaemia and Insulinaemia

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Glucose Reference 1
* Other: Glucose Reference 2
* Other: Glucose Reference 3
* Other: Wheat Yellow Noodle
* Other: Beta-glucan yellow Noodle
* Other: Rice Roll
* Other: Rice Roll with resistant starch
* Other: Sucrose Jelly
* Other: Isomaltulose Jelly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Males Chinese ethnicity Age ≥21 and ≤ 40 years Body mass index between 18.5 to 25 kg/m2 Normal blood pressure ≤140/90 mmHg Fasting blood glucose <6.0 mmol/L In general good health Exclusion Criteria: Current smoker Have metabolic diseases (such as diabetes, hypertension etc) Have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency) Have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics) Have an ongoing infection or currently undergoing treatment at the time of screening Have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) Have active Tuberculosis (TB) or currently receiving treatment for TB Intolerances or allergies to any foods Partake in sports at the competitive and/or endurance levels Intentionally restrict food intake

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glucose Reference 1<br>50g glucose dissolve in 250 ml of water | Other: Glucose Reference 1<br>* Glucose contains 50g of available carbohydrates<br>|
| Other: Glucose Reference 2<br>50g glucose dissolve in 250 ml of water | Other: Glucose Reference 2<br>* Glucose contains 50g of available carbohydrates<br>|
| Other: Glucose Reference 3<br>50g glucose dissolve in 250 ml of water | Other: Glucose Reference 3<br>* Glucose contains 50g of available carbohydrates<br>|
| Experimental: Wheat Yellow Noodle<br>Boiled 170.6g of wheat yellow noodle | Other: Wheat Yellow Noodle<br>* Wheat Yellow Noodle will contain 50g of available carbohydrate<br>|
| Experimental: Beta-glucan Yellow Noodle<br>Boiled 230.4g of beta-glucan yellow noodle. | Other: Beta-glucan yellow Noodle<br>* Beta-glucan yellow noodle will contain 50g of available carbohydrate<br>|
| Experimental: Rice Roll<br>Steamed 197.6g of rice roll | Other: Rice Roll<br>* Rice Roll will contain 50g of available carbohydrate<br>|
| Experimental: Rice Roll with resistant starch<br>Steamed 232.6g of rice roll fortified with resistant starch | Other: Rice Roll with resistant starch<br>* Rice Roll fortified with resistant starch will contain 50g of available carbohydrate<br>|
| Experimental: Sucrose jelly<br>Jelly made with 25g of sucrose and 48g of wheat white bread | Other: Sucrose Jelly<br>* Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of sucrose<br>|
| Experimental: Isomaltulose jelly<br>Jelly made with 25g of isomaltulose and 48g of wheat white bread | Other: Isomaltulose Jelly<br>* Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of Isomaltulose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Blood glucose will be collected using finger prick method and analysed using Hemocue analyser | up to 180 minutes | 
| Insulin | Blood glucose will be collected using finger prick method and analysed using Cobas analyser | up to 180 minutes |