Food Modification to Alter Glycaemia and Insulinaemia

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT03706378
• Lead Sponsor: Clinical Nutrition Research Centre, Singapore

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.

Study Timeline

• Study Start: 2017-08-18
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-16
• Primary Completion: 2019-04-04
• Study Completion: 2019-04-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Insulin	up to 180 minutes	Blood glucose will be collected using finger prick method and analysed using Cobas analyser
Glucose	up to 180 minutes	Blood glucose will be collected using finger prick method and analysed using Hemocue analyser

Trial Locations

Locations (1)

Clinical Nutrition Research Centre; 🇸🇬 Singapore, Singapore