NCT04063137

Black Rice Anthocyanin in Mixed Meals: Influence on Postprandial Glycaemic and Lipid Responses Among Healthy Individuals

Completed NA Last updated 15 November 2024

What this trial tests

NA trial testing Anthocyanin fortified bread with beef patty (35% fat) in Postprandial Hyperglycemia in 24 participants. Completed in 30 December 2020.

Timeline

16 September 2019

Primary endpoint
30 December 2020

30 December 2020

Quick facts

Lead sponsor	National University of Singapore
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	prevention
Enrollment	24
Start date	16 September 2019
Primary completion	30 December 2020
Estimated completion	30 December 2020
Sites	1 location across Singapore

Drugs / interventions tested

• Anthocyanin fortified bread with beef patty (35% fat)

Conditions studied

• Postprandial Hyperglycemia — all drugs for Postprandial Hyperglycemia →
• Lipidemia — all drugs for Lipidemia →

Sponsor

National University of Singapore

Who can join

Adults 21 to 65, any sex, with Postprandial Hyperglycemia or Lipidemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The diabetes epidemic is a pertinent concern globally. The prevalence of this metabolic disease among adults had been disclosed by the World health Organisation (WHO), reporting a total of 422 million diabetic adults and 3.7 million diabetic deaths in 2016, with Asian countries contributing more than 60% of the world's diabetic population. Due to its economic and social repercussions, preventive strategies are implemented at a population level. The implementation of a diet low in glycaemic index (GI) has been widely adopted as part of diabetes management strategies to prevent and control Type 2 Diabetes Mellitus (T2DM) as the consumption of food with low GI has shown to improve glycaemic control, lipid profile, and reduce systemic inflammation. Other strategies include adopting an active lifestyle and the consumption of functional foods. In lieu of this, the composition of food products may be altered by incorporating edible plant-based functional components with carbohydrase-inhibiting properties. Black rice has been proposed as a viable source of functional ingredients, namely anthocyanins, not only because of its potential benefits to health that has been established by numerous in-vitro studies, but also it is easily sourced for in Asia as it is widely cultivated.

In this study, black rice anthocyanin-fortified bread serves as a replacement to white bread as the staple to the subject's diet, in a mixed meal setting. The fortified bread is hypothesised to improve glycemic responses over white bread, offering a lower GI food alternative to the conventional staple.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Postprandial glycemic and lipidemic effects of black rice anthocyanin extract fortification in foods of varying macronutrient compositions and matrices.
   Ou SJL, Yang D, Pranata HP, Tai ES, et al · · 2023 · cited 11× · PMID 37914734 · DOI 10.1038/s41538-023-00233-y