Post-prandial GlycaemiaNCT04748575
Effect of Acai Berry Consumption on Blood Glucose Levels in Healthy Adults
A study testing Acai smoothie in people with Post-prandial Glycaemia, run by St Mary's University College at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-prandial Glycaemia
- What is being tested?
- Acai smoothie
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2020to 29 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 18.5 - 24.9 kg/m2.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Acai smoothie, Placebo smoothie
- Keywords
- Acai (Euterpe oleracea), acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acai smoothieDietary supplement
Smoothie containing 150g acai pulp
Placebo smoothieDietary supplement
Control smoothie matched nutritionally (macronutrients) and sensorially to the acai smoothie.
| Study group | Role | What they receive |
|---|---|---|
| Acai smoothie consumption | Experimental | 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. Receives: Dietary Supplement: Acai smoothie |
| Placebo smoothie consumption | Experimental | 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. Receives: Dietary Supplement: Placebo smoothie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Finger capillary sample collected by micro cuvette (Glucose 201, HemoCue, UK) and analysed electronically (HemoCue 201+, HemoCue,UK).
Measured: Baseline to 120 minutes after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start5 Nov 2020
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-prandial GlycaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised double-blind crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748575
- Sponsor's protocol ID
- SMU_ETHICS_2020-21_111
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Acai Berry Supplementation on Post-prandial Glycaemia in Healthy Adults: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04748575
- Acronym / sponsor ID
- SMU_ETHICS_2020-21_111
- Conditions
- Post-prandial Glycaemia
- Keywords
- Acai (Euterpe oleracea), acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised double-blind crossover
| Arm | Type | Receives |
|---|---|---|
| Acai smoothie consumption | Experimental | Dietary Supplement: Acai smoothieParticipants (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. |
| Placebo smoothie consumption | Experimental | Dietary Supplement: Placebo smoothieParticipants (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI of 18.5 - 24.9 kg/m2.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acai smoothieSmoothie containing 150g acai pulp | Dietary supplement | Acai smoothie consumption |
| Placebo smoothieControl smoothie matched nutritionally (macronutrients) and sensorially to the acai smoothie. | Dietary supplement | Placebo smoothie consumption |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acai smoothie in people with Post-prandial Glycaemia, run by St Mary's University College at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: Baseline to 120 minutes after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.