Clinical trial NCT03985566: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Alchemy Foodtech Pte Ltd
First posted: 2019-06-13
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in glucose response
timeFrame: 2 hour
measure: Change in insulin response
timeFrame: 2 hour
Secondary outcomes:
measure: Change in ghrelin level
timeFrame: 2 hour
measure: Change in glucagon-like peptide 1 (GLP-1) level
timeFrame: 2 hour
measure: Change in satiety rating
timeFrame: 2 hour
measure: Change in glucose trajectories over 14 days of continous glucose monitoring
timeFrame: 14 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Mei Hui Liu
role: PRINCIPAL_INVESTIGATOR
References: