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Diabetes Mellitus, Type 2NCT03985566

Effects of Fixed Meals With Special Formulated Rice on Blood Glucose Levels of Healthy Volunteers.

A study testing Fibre Grain and Jasmine white rice in people with Diabetes Mellitus, Type 2, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to compare Diabetec® Fibre Grains (FIbre Grains) in a mixed meal setting with Jasmine rice. This is to see whether partial replacement of white rice with Fibre Grains can reduce postprandial blood glucose control. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Fibre Grain and Jasmine white rice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteSingapore
Study dates
3 Jul 2018to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ability to give informed consent
  • Age between 21-65 years old
  • Overtly healthy males or females, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
  • Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
  • Not on any regular medications (western / traditional medicine). Nutritional supplements with established chemical composition that can be ascertained and clearly recorded is acceptable. However, subjects using traditional medicine (with compositions that cannot be ascertained) will be excluded in this study
  • Have venous access sufficient to allow for blood sampling as per the protocol
  • Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • Family history of diabetes (Parents and/or grandparents with history of diabetes).

Who cannot join

  • History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data
  • Known or ongoing psychiatric disorders within 3 years
  • Regularly use known drugs of abuse within 3 years
  • Women who are pregnant or lactating
  • Have donated blood of more than 500 mL within 4 weeks of study enrolment
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females):• 1 unit = 12 oz or 360 mL of beer; • 5 oz or 150 mL of wine; • 1.5 oz or 45 mL of distilled spirits
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  • Uncontrolled hypertension (blood pressure [BP] >160/100mmHg
  • Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 19 Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study
  • Known allergy to insulin
  • History of bleeding diathesis or coagulopathy
  • Any of the following laboratory values at screening:Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)
  • Clinically significant (as determined by investigator) abnormalities on laboratory examination that will increase risk to the patient or interfere with data integrity
  • Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
  • Significant change in weight (+/- 5%) during the past month

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University of Singapore

    Singapore, 118177

Other trials in Singapore

About this study

The aim of the study is to compare Diabetec® Fibre Grains (FIbre Grains) in a mixed meal setting with Jasmine rice. This is to see whether partial replacement of white rice with Fibre Grains can reduce postprandial blood glucose control.

Read the detailed description

Lifestyle modification, in particular adopting an appropriate dietary pattern, is generally accepted as the cornerstone for the treatment of people with type 2 diabetes. Consumption of low GI food has shown to improve glycemic control, lipid profile and reduce systemic inflammation. However, there are few dietary intervention studies attempting to change the GI of food by changing the staple carbohydrates. In this study, formulated rice with special fibre enrichment, Fibre Grains, was used to replace rice as the staple carbohydrates in one's diet. This fibre enriched rice has been previously tested to have a lower GI than normal rice while still able to preserve all the sensory characteristics of normal rice. With rice being a staple to Asians, this specially formulated fibre enriched rice offers a lower GI alternative to the conventional rice without affecting the people dietary preference.

Being tested
Fibre Grain, Jasmine white rice
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fibre GrainDietary supplement

    Healthy subjects will be provided with 30% Fibre Grain in a mixed meal. After consumption of the meal, the glucose and insulin response will be compared.

  • Jasmine white riceDietary supplement

    Healthy subjects will be provided with Jasmine white rice in a mixed meal. After consumption of the meal, the glucose and insulin response will be compared.

Study groups in NCT03985566
Study groupRoleWhat they receive
Fibre GrainsExperimentalFibre grains were used to partially replaced Jasmine white rice in this arm.
Receives: Dietary Supplement: Fibre Grain
Jasmine white ricePlacebo comparatorJasmine white rice is used as a control to compare the outcome.
Receives: Dietary Supplement: Jasmine white rice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glucose response

    A mixed meal tolerance test will be done to collect blood samples for glucose analysis at 0 min, 15 min, 30 min, 45 min, 60 min , 90 min and 120 min.The change in glucose response will be measured by comparing incremental area under the curve (iAUC) after ingestion of Fibre Grain meal and control Jasmine white rice meal.

    Measured: 2 hour

  2. Change in insulin response

    A mixed meal tolerance test will be done to collect blood samples for glucose analysis at 0 min, 15 min, 30 min, 45 min, 60 min , 90 min and 120 min.The change in insulin response will be measured by comparing incremental area under the curve (iAUC) after ingestion of Fibre Grain meal and control Jasmine white rice meal.

    Measured: 2 hour

Secondary outcomes (4)

  1. Change in ghrelin level

    A mixed meal tolerance test will be done to collect blood samples for ghrelin analysis at 0 min, 30 min, 60 min , 90 min and 120 min.The change in ghrelin level will be measured by comparing AUC after ingestion of Fibre Grain meal and control Jasmine white rice meal.

    Measured: 2 hour

  2. Change in glucagon-like peptide 1 (GLP-1) level

    A mixed meal tolerance test will be done to collect blood samples for GLP-1 analysis at 0 min, 30 min, 60 min , 90 min and 120 min.The change in GLP-1 level will be measured by comparing AUC after ingestion of Fibre Grain meal and control Jasmine white rice meal.

    Measured: 2 hour

  3. Change in satiety rating

    A visual analogue scale (VAS) will be presented to the participants at 0, min, 30 min, 60 min , 90 min and 120 min, to indicate how they feel in response to 4 given statements by marking an "X" on a 100-mm line.

    At time T=15 min, palatability of the treatment was assessed by five characteristics, from bad (0 mm) to good (100 mm). These characteristics were visual appeal, smell, taste, texture, and overall pleasantness of the meal given. Scores were determined by measuring the distance (in mm) from the let starting point of the line to the intersection of the "X". Subjects did not discuss their ratings.The primary outcome was area under the curve (AUC) for responses on the VAS calculated using the trapezoidal rule.

    Measured: 2 hour

  4. Change in glucose trajectories over 14 days of continous glucose monitoring

    FreeStyle ® Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Singapore) was used for continuous glucose monitoring. During the study time frame, subjects were supplied with frozen meals for lunch and dinner to bring home. They were randomized to consumed 6 different combinations of food at 3 replacement levels for the rice: control (0%), 15% or 30% Fibre Grains. On day 14, subjects returned to the study facility to remove the flash glucose monitoring sensor and return the flash glucose monitoring reader. Subsequently, data was extracted from the reader by the study personnel. Glucose values were exported into Microsoft excel for visualization of the glucose trend over 14 days.

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2019
  2. Study start3 Jul 2018
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
This study is a within-subject cross-over trial design to assess the glycemic response of fibre enriched rice consumer by human subjects as compared to normal non-enriched rice in a mixed meal setting.
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03985566
Sponsor's protocol ID
2017/01126
Other IDs
2017
Status last verified
Jul 2021
First submitted
10 Jun 2019
Last updated
26 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The plan for individual participant data will be discussed with collaborator to decide whether to be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Fibre Grain and Jasmine white rice in people with Diabetes Mellitus, Type 2, run by National University of Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glucose response (time frame: 2 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03985566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.

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