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

Postprandial Hyperglycemia Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Black rice anthocyanin-fortified bread, compared to white bread as a control, is hypothesised to improve glycaemic control and serum lipid profiles in a mixed meal setting. The aim of this research is to to assess the influence of black rice anthocyanin on postprandial blood glucose and insulinemic responses, and lipid profiles.

The aim of the research is to contribute to the prevention of diabetes by investigating how the incorporation of functional ingredients in carbohydrate-based foods will influence glycaemic and lipid panel profiles in a mixed meal setting. A human in-vivo intervention study will be conducted to assess the glycaemic and lipid responses of anthocyanin-fortified bread as compared to white bread, served with a ground beef patty to simulate the mixed meal. The approximate time to complete study recruitment will be 4 weeks.

Healthy, non-smoking subjects aged 21 to 65 will be recruited in this study. There will be a total of 2 visits (excluding 1 screening session), with the duration of each visit approximately 4-5 h. The study procedures will be conducted in Investigational Medicine Unit (IMU). During the each visit, subjects will undergo a mixed meal tolerance test. Test foods will be freshly prepared on the day of the visit in Food Science amp; Technology Programme food preparation area situated at Block S14 level 5, Science Drive 2, using food-grade ingredients. Only small quantities of bread will be prepared each day (3 to 4). The subject's glycemic response to the control meal (white bread) will be compared to their response after consumption of anthocyanin-fortified bread in a mixed meal setting. An improvement in postprandial blood glucose response and lipid panel profiles in response to the mixed meals will show that the anthocyanin-fortification is effective in offering better control over glycaemic and lipid profiles. ;

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperlipidemias
• Lipidemia
• Postprandial Hyperglycemia

• NCT number: NCT04063137
• Study type: Interventional
• Source: National University, Singapore
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Completion date: December 30, 2020