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Clinical Trials/NCT03706378
NCT03706378
Completed
Not Applicable

Food Modification to Alter Glycaemia and Insulinaemia

Clinical Nutrition Research Centre, Singapore1 site in 1 country14 target enrollmentAugust 18, 2017
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Clinical Nutrition Research Centre, Singapore
Enrollment
14
Locations
1
Primary Endpoint
Insulin
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 18, 2017
End Date
April 4, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Clinical Nutrition Research Centre, Singapore
Responsible Party
Principal Investigator
Principal Investigator

JeyaKumar Henry

Principal Investigator

Clinical Nutrition Research Centre, Singapore

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

Outcomes

Primary Outcomes

Insulin

Time Frame: up to 180 minutes

Blood glucose will be collected using finger prick method and analysed using Cobas analyser

Glucose

Time Frame: up to 180 minutes

Blood glucose will be collected using finger prick method and analysed using Hemocue analyser

Study Sites (1)

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