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Clinical Trials/NCT03706378
NCT03706378CompletedNot Applicable

Food Modification to Alter Glycaemia and Insulinaemia

Clinical Nutrition Research Centre, Singapore2 sites in 1 country14 target enrollmentStarted: August 18, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
14
Locations
2
Primary Endpoint
Insulin

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
21 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Glucose Reference 1

Other

50g glucose dissolve in 250 ml of water

Intervention: Glucose Reference 1 (Other)

Glucose Reference 2

Other

50g glucose dissolve in 250 ml of water

Intervention: Glucose Reference 2 (Other)

Glucose Reference 3

Other

50g glucose dissolve in 250 ml of water

Intervention: Glucose Reference 3 (Other)

Wheat Yellow Noodle

Experimental

Boiled 170.6g of wheat yellow noodle

Intervention: Wheat Yellow Noodle (Other)

Beta-glucan Yellow Noodle

Experimental

Boiled 230.4g of beta-glucan yellow noodle.

Intervention: Beta-glucan yellow Noodle (Other)

Rice Roll

Experimental

Steamed 197.6g of rice roll

Intervention: Rice Roll (Other)

Rice Roll with resistant starch

Experimental

Steamed 232.6g of rice roll fortified with resistant starch

Intervention: Rice Roll with resistant starch (Other)

Sucrose jelly

Experimental

Jelly made with 25g of sucrose and 48g of wheat white bread

Intervention: Sucrose Jelly (Other)

Isomaltulose jelly

Experimental

Jelly made with 25g of isomaltulose and 48g of wheat white bread

Intervention: Isomaltulose Jelly (Other)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Clinical Nutrition Research Centre, Singapore
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

JeyaKumar Henry

Principal Investigator

Clinical Nutrition Research Centre, Singapore

Study Sites (2)

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