Glycemic Evaluation of Novel Staple Foods

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabete Type 2
• Intervention / Treatment: Dietary supplement: Modified Functional Foods; Dietary supplement: Control Functional Foods

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 118177
    • National University of Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Functional Foods (Treatment); Anthocyanin black rice extract powder (ABREP)-fortified bread, microfluidic co-flow noodles, and 5ibrePlus™-fortified white rice for breakfast, lunch, and dinner respectively served in a mixed meal.	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.
Placebo Comparator: Control Functional Foods (Control); White bread, beehoon noodles, and jasmine white rice for breakfast, lunch, and dinner respectively served in a mixed meal.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National University of Singapore
• Investigators: Principal Investigator: Mei Hui Liu, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): May 19, 2023
• Study Completion (Actual): May 19, 2023

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2019/00952

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No