Glycemic Evaluation of Novel Staple Foods

Diabetes Mellitus Clinical Trial

Official title:

Glycemic Evaluation of Novel Staple Foods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399134
• Other study ID #: 2019/00952
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 19, 2023

Study information

• Verified date: June 2023
• Source: National University of Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the combined effects of functional foods (i.e. Anthocyanin fortified bread, Microfluidic co-flow noodles, 5ibrePlus™-fortified white rice) is investigated in an ad-libitum diet and their contributions to diabetes management.

Description:

Research has confirmed that a food's glycemic effect cannot be accurately predicted from the type and amount of carbohydrates it contains, as the rate at which the carbohydrates is digested and released into the bloodstream is influenced by many factors such as the food's physical form, its fat, protein and fibre content, and the chemical structure of its carbohydrates. For these reasons, it is possible to produce food from the same group with different effects on blood glucose. Consumption of low GI food has shown to improve glycemic control, lipid profile and reduce systemic inflammation. With bread, noodles and rice being the staple food for many Singaporeans, functional staple food alternatives offer a lower GI alternative without greatly affecting the population's dietary preference. Preliminary studies for each functional staple food alternative (for bread, noodles, and rice) had reflected improved glycaemic responses compared to their staple counterparts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 19, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chinese ethnicity

• English-speaking

• Age between 21 - 70 years old inclusive.

• Confirmed Type 2 Diabetes with HbA1c level of less than 10%

• Not on prandial insulin therapy

• Subjects with stable medical problems not limited to hypertension and hyperlipidemia

Exclusion Criteria:

• Current smoker or use of tobacco products within the 3 months

• Vegetarian or other dietary restrictions that would not allow the subject to consume the test meal.

• Persons with electronic medical implants (e.g. pacemaker).

• Persons with known or ongoing psychiatric disorders or drug abuse within 3 years.

• Women who are pregnant or lactating.

• Persons with an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females). 1 unit is equivalent to:

• 12 oz or 360 mL of beer;

• 5 oz or 150 mL of wine;

• 1.5 oz or 45 mL of distilled spirits.

• Persons with active infection(s) requiring systemic, antiviral or antimicrobial therapy that will not be completed prior to the first study visit

• Persons who have undergone treatment with any investigational drug or biological agent within one (1) month of screening or plans to enroll in another study involving investigational drugs/biological agents during the duration of this study.

• Persons with significant change in weight (+/- 5%) during the past month.

• Persons with a known allergy to rice bran, dietary fiber, alginate and other study components (anthocyanins, soy protein).

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Modified Functional Foods
Subjects will be provided with ABREP-fortified bread, microfluidic co-flow noodles, and 5ibrePlus™-fortified white rice served in a mixed meal. ABREP-fortified bread: Anthocyanins are known to exert anti-diabetic effects through modulating digestion, glucose uptake, insulin secretion and sensitivity. Moreover, inhibitory effects of anthocyanins on various carbohydrases, including a-glucosidase and a-amylase have been widely reported. Microfluidic co-flow noodles: Microfluidic technology is employed to design noodle-food structures consisting of a mix of soy protein isolate and alginate as gelling agents to offer a type of novel noodles with proteins and negligible carbohydrate content. 5ibrePlus™-fortified white rice: 5ibrePlus™ is a patented novel fibre grain product by Alchemy Foodtech Pte. Ltd (WO 2017/142477) with reduced GI. Its main constituents are insoluble resistant starch and soluble fibre.
• Control Functional Foods
Subjects will be provided with control function foods including white bread, beehoon noodles, and jasmine white rice served in a mixed meal.

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University of Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemic response of novel staple foods in Type 2 diabetics	Incremental area under the curve (iAUC) post prandial glycemic response from continuous glucose monitoring of diet incorporated with novel staple foods, in comparison to control staple foods, in Type 2 diabetic individuals.	5 weeks