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

National University of Singapore

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Dietary Supplement: Fibre Grain

Dietary Supplement: Jasmine white rice

Study type

Interventional

Funder types

Other

Identifiers

NCT03985566

2017/01126

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts 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