Food Modification to Alter Glycaemia and Insulinaemia

Diabetes Clinical Trial

Official title:

Food Modification to Alter Glycaemia and Insulinaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706378
• Other study ID #: 2017/00538
• Status: Completed
• Phase: N/A
• Start date: August 18, 2017
• Est. completion date: April 4, 2019

Study information

• Verified date: May 2019
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 4, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Glucose Reference 1
Glucose contains 50g of available carbohydrates
• Glucose Reference 2
Glucose contains 50g of available carbohydrates
• Glucose Reference 3
Glucose contains 50g of available carbohydrates
• Wheat Yellow Noodle
Wheat Yellow Noodle will contain 50g of available carbohydrate
• Beta-glucan yellow Noodle
Beta-glucan yellow noodle will contain 50g of available carbohydrate
• Rice Roll
Rice Roll will contain 50g of available carbohydrate
• Rice Roll with resistant starch
Rice Roll fortified with resistant starch will contain 50g of available carbohydrate
• Sucrose Jelly
Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of sucrose
• Isomaltulose Jelly
Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of Isomaltulose

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore	Health Promotion Board, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	Blood glucose will be collected using finger prick method and analysed using Hemocue analyser	up to 180 minutes
Primary	Insulin	Blood glucose will be collected using finger prick method and analysed using Cobas analyser	up to 180 minutes