Clinical trial NCT04748575: Effect of Acai Berry Consumption on Blood Glucose Levels in Healthy Adults
Official title: Effect of Acute Acai Berry Supplementation on Post-prandial Glycaemia in Healthy Adults: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-prandial Glycaemia
Keywords: Acai (Euterpe oleracea), acute
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised double-blind crossover
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

• BMI of 18.5 - 24.9 kg/m2.

Exclusion Criteria:

* Known allergy to acai/berries or lactose.
* Pregnant or lactating.
* Alcohol/drug dependency.
* Smoking.
* Currently on an energy-restriction diet or have had a body weight change \>10% in last 2 months.
* Eating disorders.
* Diagnosed with diabetes or another chronic condition.
* Taking chronic medication.
* Allergy to any of materials used in, or an unsurmountable fear of, the finger-prick procedure.

Primary outcomes:
measure: Blood glucose
timeFrame: Baseline to 120 minutes after intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Marys University
Study officials:
References: