Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05008978 |
| Other study ID # |
2019/00691 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2019 |
| Est. completion date |
April 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Clinical Nutrition Research Centre, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The health benefits of fruits and their importance in a healthy diet have long been known.
Several intervention studies have included the promotion of fruit as part of the healthy diet
and epidemiologic evidences have demonstrated that a diet rich in fruits is associated with
the reduction in the risk of many chronic diseases, including type 2 diabetes. Such
beneficial health effects of fruits could be attributed to the presence of dietary fiber,
micronutrients (vitamins and minerals), antioxidants and phytochemicals found in them.
However, up to our knowledge, no study has investigate the time-course effects on the
co-ingestion of fruits with other food product on postprandial glycaemic response (GR) and
insulinaemic response (IR). The time-course effect will be examined in this study in order to
determine its optimal effect on GR and IR. The investigators also aimed to compare the
effects of varying micronutrients content in fruits on GR and IR.
Description:
Type 2 diabetes is one of the most common non-communicable diseases found in 415 million
adults worldwide in 2015 and the number is expected to increase to 642 million in 2040. This
has serious consequences for healthcare expenditure as it has been estimated that the global
health expenditure on diabetes is at least USD$673 billion in 2015 and is forecasted to
increase to USD$802 billion in 2040. This creates a major public health burden and effective
treatments and prevention strategies are necessary. The Asian phenotype has been shown to be
more susceptible to diabetes compared to the Western phenotype where more than half (56%) of
the population with type 2 diabetes lived in the South-East Asia Region or the Western
Pacific Region in 2015.Pharmacological methods through the use of drugs and insulin remains
as the conventional strategy in the management of type 2 diabetes. However, in recent years,
dietary interventions have been used as a mean to prevent or delay the onset of type 2
diabetes. Food has now become the new medicine and a healthy diet is widely believed to play
an important role in the prevention of the development of type 2 diabetes.The health benefits
of fruits and their importance in a healthy diet have long been established. Several
intervention studies have included the promotion of fruit as part of the healthy diet with
epidemiological evidences demonstrating that a diet rich in fruits is associated with a
reduction in the risk of many chronic diseases, including type 2 diabetes. Such beneficial
health effects of fruits may be attributed to the presence of dietary fibre, micronutrients
(vitamins and minerals), antioxidants and phytochemicals found in them. However, to our
knowledge, no study has investigated the time-course effects of co-ingesting fruits with a
carbohydrate-based food product on postprandial glycaemic response (GR) and insulinaemic
response (IR). GR and IR is the effect a food product has on blood glucose and insulin levels
respectively, after consumption. Better control of GR and IR were found to be associated with
a lower risk of development of type 2 diabetes and other cardiovascular diseases. Studies
have shown that soluble dietary fibre, which are found in fruits, decrease the rise in blood
glucose and insulin level. Addition of fibre as a food ingredient was also found to modulate
glucose response by improving insulin sensitivity. Antioxidants and phytochemicals in fruits
have also been hypothesized to improve insulin sensitivity and hence protect against
diabetes. In the second part of the study, the investigators aim to compare the effects of
varying micronutrients content in fruits on GR and IR. Fruits have highly variable contents
of fibre, antioxidants, other nutrients, and phytochemicals that may jointly influence the
risk of metabolic diseases. It has been reported that the consumption of higher anthocyanins
content had an inverse relationship with the risk of developing type 2 diabetes. Varying
content of resveratrol, chlorogenic acid and naringin have also been reported to have an
association with the risk of type 2 diabetes in animal studies. Due to the heterogeneous
composition found in fruits, it may be plausible that different fruits have varying effects
on GR and IR. Therefore, the investigators hypothesized that varying micronutrients content
in fruit plays an essential role in the association with diabetes risk due to a difference in
GR and IR. In this proposed study, the investigators will thus determine whether different
micronutrients content present in different fruits have an effect on postprandial on GR and
IR.
