The Glycaemic Response of Local Foods Using the Continuous Glucose Monitoring System

Diabetes Clinical Trial

Official title:

The Glycaemic Response of Local Foods Using the Continuous Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703544
• Other study ID #: 2017/00994
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: May 22, 2020

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

This study is carried out to determine the effect of high and low GI of local foods using Continuous Glucose Monitoring System (CGMS™) on 24 hour blood glucose profiles.

Description:

Glycemic Index (GI) is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as Participants will have a lower impact on blood glucose concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose profiles in healthy Chinese male participants. There will be two test sessions where participants will consume either a high or low GI breakfast, lunch, snack and dinner. Participants will take part in two test sessions (each spanning over 3 days and to monitor the participants' glycemic response using a Continuous Glucose Monitoring System (CGMS) throughout the period.This study specifically attempts to see how having high and low GI locally consumed meals impact on blood glucose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 22, 2020
• Est. primary completion date: May 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Chinese, male

• Age between 21-50 years

• Body mass index between 18 to 25 kg/m2

• Normal blood pressure (<140/90 Hgmm)

• Fasting blood glucose < 6 mmol/L

Exclusion Criteria:

• Current Smoker

• Have any metabolic diseases (such as diabetes, hypertension etc)

• Have known 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

• 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

• Have intolerances or allergies to any foods

• Partake in sports at the competitive and/or endurance levels

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• High glycemic index
Wheat yellow noodle, glutinous rice, tea with sucrose, biscuits, jelly made with sucrose and teriyaki chicken rice.The foods provided have been tested as high glycemic index. Participants' blood glucose will be monitored using the Continuous Glucose Monitor.
• Low glycemic index
Beta-glucan yellow noodle, basmati rice, tea with isomaltulose, biscuits, jelly made with isomaltulose and mung bean noodles.The foods provided have been tested as low glycemic index.Participants' blood glucose will be monitored using the Continuous Glucose Monitor.

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	Daily blood glucose profile	The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS for breakfast, lunch, snack and dinner.	24 hours