NCT03706378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

October 11, 2018

Last Update Submit

May 10, 2019

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

  • Glucose

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

    up to 180 minutes

  • Insulin

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

    up to 180 minutes

Study Arms (9)

Glucose Reference 1

OTHER

50g glucose dissolve in 250 ml of water

Other: Glucose Reference 1

Glucose Reference 2

OTHER

50g glucose dissolve in 250 ml of water

Other: Glucose Reference 2

Glucose Reference 3

OTHER

50g glucose dissolve in 250 ml of water

Other: Glucose Reference 3

Wheat Yellow Noodle

EXPERIMENTAL

Boiled 170.6g of wheat yellow noodle

Other: Wheat Yellow Noodle

Beta-glucan Yellow Noodle

EXPERIMENTAL

Boiled 230.4g of beta-glucan yellow noodle.

Other: Beta-glucan yellow Noodle

Rice Roll

EXPERIMENTAL

Steamed 197.6g of rice roll

Other: Rice Roll

Rice Roll with resistant starch

EXPERIMENTAL

Steamed 232.6g of rice roll fortified with resistant starch

Other: Rice Roll with resistant starch

Sucrose jelly

EXPERIMENTAL

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

Other: Sucrose Jelly

Isomaltulose jelly

EXPERIMENTAL

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

Other: Isomaltulose Jelly

Interventions

Glucose Reference 1OTHER

Glucose contains 50g of available carbohydrates

Glucose Reference 1
Glucose Reference 2OTHER

Glucose contains 50g of available carbohydrates

Glucose Reference 2
Glucose Reference 3OTHER

Glucose contains 50g of available carbohydrates

Glucose Reference 3
Wheat Yellow NoodleOTHER

Wheat Yellow Noodle will contain 50g of available carbohydrate

Wheat Yellow Noodle
Beta-glucan yellow NoodleOTHER

Beta-glucan yellow noodle will contain 50g of available carbohydrate

Beta-glucan Yellow Noodle
Rice RollOTHER

Rice Roll will contain 50g of available carbohydrate

Rice Roll
Rice Roll with resistant starchOTHER

Rice Roll fortified with resistant starch will contain 50g of available carbohydrate

Rice Roll with resistant starch
Sucrose JellyOTHER

Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of sucrose

Sucrose jelly
Isomaltulose JellyOTHER

Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of Isomaltulose

Isomaltulose jelly

Eligibility Criteria

Age21 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy male participants
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary FiberDietary CarbohydratesCarbohydratesPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 16, 2018

Study Start

August 18, 2017

Primary Completion

April 4, 2019

Study Completion

April 4, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

SG(1)