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

NCT ID: NCT04748575

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2020-12-29

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.

Conditions

Post-prandial Glycaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Acai smoothie consumption

Participants (n=5) in this arm were randomly allocated to consume the acai smoothie at the first intervention. After a 7 day wash-out period, the participants consumed the placebo smoothie.

Group Type: EXPERIMENTAL

Acai smoothie

Intervention Type: DIETARY_SUPPLEMENT

Smoothie containing 150g acai pulp

Placebo smoothie consumption

Participants (n=5) in this arm were randomly allocated to consume the placebo smoothie at the first intervention. After a 7 day wash-out period, the participants consumed the acai smoothie.

Group Type: EXPERIMENTAL

Placebo smoothie

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Acai smoothie

Smoothie containing 150g acai pulp

Intervention Type: DIETARY_SUPPLEMENT

Placebo smoothie

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St Mary's University College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Marys University

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

SMU_ETHICS_2020-21_111

Identifier Type: -

Identifier Source: org_study_id