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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Fibre Grain

Jasmine white rice

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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
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

Sites / Locations

National University of Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fibre Grains

Jasmine white rice

Arm Description

Fibre grains were used to partially replaced Jasmine white rice in this arm.

Jasmine white rice is used as a control to compare the outcome.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT03985566

First Posted

June 10, 2019

Last Updated

July 23, 2021

Sponsor

National University of Singapore

Collaborators

Alchemy Foodtech Pte Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03985566

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

July 3, 2018 (Actual)

Primary Completion Date

December 30, 2019 (Actual)

Study Completion Date

December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Singapore

Collaborators

Alchemy Foodtech Pte Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

Participant

Masking Description

Fibre Grains have similar appearance to normal Jasmine white rice. It is made up of functional fibre extruded into grain-shaped food particles .

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fibre Grains

Arm Type

Experimental

Arm Description

Fibre grains were used to partially replaced Jasmine white rice in this arm.

Arm Title

Jasmine white rice

Arm Type

Placebo Comparator

Arm Description

Jasmine white rice is used as a control to compare the outcome.

Intervention Type

Dietary Supplement

Intervention Name(s)

Fibre Grain

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Jasmine white rice

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in glucose response

Description

Time Frame

2 hour

Title

Change in insulin response

Description

Time Frame

2 hour

Secondary Outcome Measure Information:

Title

Change in ghrelin level

Description

Time Frame

2 hour

Title

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

Description

Time Frame

2 hour

Title

Change in satiety rating

Description

Time Frame

2 hour

Title

Change in glucose trajectories over 14 days of continous glucose monitoring

Description

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mei Hui Liu

Organizational Affiliation

National University of Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University of Singapore

City

Singapore

ZIP/Postal Code

118177

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The plan for individual participant data will be discussed with collaborator to decide whether to be shared.

Learn more about this trial

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

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