Clinical trial NCT05399134: Glycemic Evaluation of Novel Staple Foods
Official title: Glycemic Evaluation of Novel Staple Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabete Type 2
Diabetes Mellitus
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Postprandial glycemic response of novel staple foods in Type 2 diabetics
timeFrame: 5 weeks
Secondary outcomes:
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: