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Completed

NCT Number: NCT04748575

Effect of Acai Berry Consumption on Blood Glucose Levels in Healthy Adults

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Marys University

London, TW1 4SX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acai smoothie

Dietary Supplement

Smoothie containing 150g acai pulp

Placebo smoothie

Dietary Supplement

Control smoothie matched nutritionally (macronutrients) and sensorially to the acai smoothie.

Primary outcomes

  1. Blood glucose

    Time frame: Baseline to 120 minutes after intervention.

    Finger capillary sample collected by micro cuvette (Glucose 201, HemoCue, UK) and analysed electronically (HemoCue 201+, HemoCue,UK).

Sponsors and collaborators

Lead sponsor

St Mary's University College

Other

Registry information

Official study title

Effect of Acute Acai Berry Supplementation on Post-prandial Glycaemia in Healthy Adults: a Randomised Controlled Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2021
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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