- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04748575
Effect of Acai Berry Consumption on Blood Glucose Levels in Healthy Adults
Effect of Acute Acai Berry Supplementation on Post-prandial Glycaemia in Healthy Adults: a Randomised Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, TW1 4SX
- St Marys University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Smoothie containing 150g acai pulp
|
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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.
|
Control smoothie matched nutritionally (macronutrients) and sensorially to the acai smoothie.
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SMU_ETHICS_2020-21_111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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