TrialReader


Food Modification to Alter Glycaemia and Insulinaemia

NCT03706378 — Not applicable, Completed, 14 participants, Singapore Institute of Food and Biotechnology Innovation

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03706378
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, other
Enrollment14 (Actual)
SponsorSingapore Institute of Food and Biotechnology Innovation (Other gov); collaborators: Health Promotion Board, Singapore
ConditionsDiabetes
InterventionsGlucose Reference 1, Glucose Reference 2, Glucose Reference 3, Wheat Yellow Noodle, Beta-glucan yellow Noodle, Rice Roll, Rice Roll with resistant starch, Sucrose Jelly, Isomaltulose Jelly (Other)
Datesstart 2017-08-18, primary completion 2019-04-04, completion 2019-04-04, first posted 2018-10-16, last updated 2019-05-13
Locations1 site in Singapore

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Diabetes All trials of Glucose Reference 1 All trials of Glucose Reference 2

-Summary

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

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Glucose Reference 1OtherOther: Glucose Reference 150g glucose dissolve in 250 ml of water
Glucose Reference 2OtherOther: Glucose Reference 250g glucose dissolve in 250 ml of water
Glucose Reference 3OtherOther: Glucose Reference 350g glucose dissolve in 250 ml of water
Wheat Yellow NoodleExperimentalOther: Wheat Yellow NoodleBoiled 170.6g of wheat yellow noodle
Beta-glucan Yellow NoodleExperimentalOther: Beta-glucan yellow NoodleBoiled 230.4g of beta-glucan yellow noodle.
Rice RollExperimentalOther: Rice RollSteamed 197.6g of rice roll
Rice Roll with resistant starchExperimentalOther: Rice Roll with resistant starchSteamed 232.6g of rice roll fortified with resistant starch
Sucrose jellyExperimentalOther: Sucrose JellyJelly made with 25g of sucrose and 48g of wheat white bread
Isomaltulose jellyExperimentalOther: Isomaltulose JellyJelly made with 25g of isomaltulose and 48g of wheat white bread
  • Glucose Reference 1 (Other): Glucose contains 50g of available carbohydrates
  • Glucose Reference 2 (Other): Glucose contains 50g of available carbohydrates
  • Glucose Reference 3 (Other): Glucose contains 50g of available carbohydrates
  • Wheat Yellow Noodle (Other): Wheat Yellow Noodle will contain 50g of available carbohydrate
  • Beta-glucan yellow Noodle (Other): Beta-glucan yellow noodle will contain 50g of available carbohydrate
  • Rice Roll (Other): Rice Roll will contain 50g of available carbohydrate
  • Rice Roll with resistant starch (Other): Rice Roll fortified with resistant starch will contain 50g of available carbohydrate
  • Sucrose Jelly (Other): Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of sucrose
  • Isomaltulose Jelly (Other): Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of Isomaltulose

+Outcome measures

Primary outcomes

  • Glucose [up to 180 minutes]: Blood glucose will be collected using finger prick method and analysed using Hemocue analyser
  • Insulin [up to 180 minutes]: Blood glucose will be collected using finger prick method and analysed using Cobas analyser

+Eligibility

Sex: Male, ages: 21 Years to 40 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Clinical Nutrition Research CentreSingaporeSingapore

+Funding

NIH grants: 2017

My Notes