Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04748575 |
| Other study ID # |
SMU_ETHICS_2020-21_111 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2020 |
| Est. completion date |
December 29, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
St Mary's University College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Type 2 Diabetes Mellitus is a chronic disease that results in hyperglycaemia. This study
aimed to identify whether the anthocyanins contained in acai berries can mitigate
postprandial glycaemia in healthy adults when consumed in conjunction with carbohydrate.
Study design was double blind randomised crossover with glycaemic levels assessed via
capillary blood samples taken at baseline and over a 2 hour post-prandial period.
Description:
Type 2 Diabetes Mellitus (T2DM) is a group of chronic metabolic disorders, characterised by
insulin resistance and relative insulin deficiency, that results in hyperglycaemia. In the UK
an estimated 4.3m people live with T2DM, and it is a major cause of kidney failure, heart
attacks, stroke, blindness and lower limb amputation. The primary digestive enzymes that
affect carbohydrate digestion and hence postprandial glycaemic levels have been identified as
α-amylase and α-glucosidase. Inhibition of these enzymes therefore reduces the rate of
glucose absorption and is the principle behind T2DM medications such as acarbose, miglitol
and voglibose. Whilst acai berries have been found to be rich in α-amylase and α-glucosidase,
no research has been conducted on healthy adults to ascertain whether the consumption of acai
berries in conjunction with carbohydrate mitigates the rise in postprandial glycaemia.
10 participants were recruited for a double blind randomised crossover study where
participants consumed smoothies containing either acai or placebo after 10 hours of fasting.
Capillary blood samples were taken at baseline then at 30 minutes intervals until 2 hours
after consumption. The study included data for sex (female/male), age (years), weight (kg),
height (cm), body mass index (kg/m2) and blood glucose (mmol/l). All data collection,
smoothies preparation, smoothies consumption and blood sampling procedures were completed at
St Mary's University during the period November-December 2020. Statistical analysis was
conducted on the data for postprandial glycaemic response to ascertain whether the
consumption of acai mitigated the glycaemic response relative to the placebo.
