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

February 9, 2021 updated by: St Mary's University College

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Dietary supplement: Acai smoothie
Smoothie containing 150g acai pulp
EXPERIMENTAL: 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.
Dietary supplement: Placebo smoothie
Control smoothie matched nutritionally (macronutrients) and sensorially to the acai smoothie.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline to 120 minutes after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St Mary's University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMU_ETHICS_2020-21_111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-prandial Glycaemia

Clinical Trials on Acai smoothie

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings