Food Modification to Alter Glycaemia and Insulinaemia

May 10, 2019 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
The study specifically aims to determine glycemic and insulinemic response of added low GI ingredients, beta-glucan, resistant starch and isomaltulose to foods.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Glucose Reference 1
50g glucose dissolve in 250 ml of water
Other: Glucose Reference 1
Glucose contains 50g of available carbohydrates
Other: Glucose Reference 2
50g glucose dissolve in 250 ml of water
Other: Glucose Reference 2
Glucose contains 50g of available carbohydrates
Other: Glucose Reference 3
50g glucose dissolve in 250 ml of water
Other: Glucose Reference 3
Glucose contains 50g of available carbohydrates
Experimental: Wheat Yellow Noodle
Boiled 170.6g of wheat yellow noodle
Other: Wheat Yellow Noodle
Wheat Yellow Noodle will contain 50g of available carbohydrate
Experimental: Beta-glucan Yellow Noodle
Boiled 230.4g of beta-glucan yellow noodle.
Other: Beta-glucan yellow Noodle
Beta-glucan yellow noodle will contain 50g of available carbohydrate
Experimental: Rice Roll
Steamed 197.6g of rice roll
Other: Rice Roll
Rice Roll will contain 50g of available carbohydrate
Experimental: Rice Roll with resistant starch
Steamed 232.6g of rice roll fortified with resistant starch
Other: Rice Roll with resistant starch
Rice Roll fortified with resistant starch will contain 50g of available carbohydrate
Experimental: Sucrose jelly
Jelly made with 25g of sucrose and 48g of wheat white bread
Other: Sucrose Jelly
Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of sucrose
Experimental: Isomaltulose jelly
Jelly made with 25g of isomaltulose and 48g of wheat white bread
Other: Isomaltulose Jelly
Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of Isomaltulose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: up to 180 minutes
Blood glucose will be collected using finger prick method and analysed using Hemocue analyser
up to 180 minutes
Insulin
Time Frame: up to 180 minutes
Blood glucose will be collected using finger prick method and analysed using Cobas analyser
up to 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Centre, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Promotion Board, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/00538

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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