Food Modification to Alter Glycaemia and Insulinaemia

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

Study Overview

• Status: Completed
• 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

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117599
    • Clinical Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Centre, Singapore
• Collaborators: Health Promotion Board, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2017
• Primary Completion (Actual): April 4, 2019
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017/00538

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No