Glycemic Evaluation of Novel Staple Foods

NCT05399134 | Completed DMC

• 1 other identifier: 2019/00952
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabete Type 2; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Modified Functional Foods (Treatment)

EXPERIMENTAL

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

Control Functional Foods (Control)

PLACEBO COMPARATOR

White bread, beehoon noodles, and jasmine white rice for breakfast, lunch, and dinner respectively served in a mixed meal.

Dietary Supplement: Control Functional Foods

Interventions

Modified Functional Foods DIETARY_SUPPLEMENT

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.

Modified Functional Foods (Treatment)

Control Functional Foods DIETARY_SUPPLEMENT

Subjects will be provided with control function foods including white bread, beehoon noodles, and jasmine white rice served in a mixed meal.

Control Functional Foods (Control)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• oz or 360 mL of beer;
• oz or 150 mL of wine;
• 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).

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, Singapore, 118177, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mei Hui Liu

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Model Details: A within-subject crossover study design is used to assess the effectiveness of incorporating novel staple food into people's diet to improve their glycemic control. Subjects will undergo two study arms: Treatment and Control. The duration of each arm is 14-days, with a 1-week washout period in between.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 1, 2022
• Study Start: January 1, 2021
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: November 15, 2024

Record last verified: 2023-06

Locations

SG (1)