Cardiovascular DiseasesAF1NCT02292329
Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome
A study testing Acai puree, frozen blended it with banana in people with Cardiovascular Diseases, run by University of Reading at 1 site in United Kingdom.
Trial summary
The purpose of this study is to carry out a randomized double blind controlled trial in 30 male subjects to investigate the effect of acai consumption on acute changes in vascular function, and to other cardiovascular markers. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Acai puree, frozen blended it with banana
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Mar 2015
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male, 30-65 aged, BMI 25-35 kg/m2, Cholesterol <8 mmol/l.
Who cannot join
- Female, BMI <25 or >35 kg/m2, Cholesterol >8mmol l-1, elevated fasting blood sugar > 6.5 mmols l-1 , elevated systolic blood pressure >150 mmHg, history of stroke or heart attack within the previous 12 months, current smoking, taking lipid lowering, blood pressure lowering or anti-blood clotting medication or taking micronutrient supplements.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, RG6 6AP
About this study
Official title: Cardiovascular Benefits of Acai in Volunteers at Risk of Metabolic Syndrome.
The purpose of this study is to carry out a randomized double blind controlled trial in 30 male subjects to investigate the effect of acai consumption on acute changes in vascular function, and to other cardiovascular markers. As a secondary aim the study will allow us to characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour period.
- Conditions
- Cardiovascular Diseases
- Being tested
- Acai puree, frozen blended it with banana, Control Macronutrient matched
- Keywords
- flow-mediated dilation, Acai polyphenols
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acai puree, frozen blended it with bananaDietary supplement
150g of acai fruit, frozen blended it with banana.
Control Macronutrient matchedDietary supplement
Macronutrient matched control in water and also prepared with banana.
| Study group | Role | What they receive |
|---|---|---|
| 150g of acai fruit | Active comparator | 150g of acai fruit in fruit smoothie form Receives: Dietary Supplement: Acai puree, frozen blended it with banana |
| Placebo control | Placebo comparator | The control will be a smoothie-like drink matched for major macro- and micro-nutrients Receives: Dietary Supplement: Control Macronutrient matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation
Measured: Change from baseline to 2h
Secondary outcomes (1)
plasma polyphenol metabolites
Measured: Change from baseline to 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Daniel Commane, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292329
- Sponsor's protocol ID
- AF1UReading
- Acronym
- AF1
- Status last verified
- May 2016
- First submitted
- 24 Sep 2014
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Alqurashi RM, Galante LA, Rowland IR, Spencer JP, Commane DM. Consumption of a flavonoid-rich acai meal is associated with acute improvements in vascular function and a reduction in total oxidative status in healthy overweight men. Am J Clin Nutr. 2016 Nov;104(5):1227-1235. doi: 10.3945/ajcn.115.128728. Epub 2016 Sep 28.
PubMed 27680990
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Benefits of Acai in Volunteers at Risk of Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT02292329
- Acronym / sponsor ID
- AF1 / AF1UReading
- Conditions
- Cardiovascular Diseases
- Keywords
- flow-mediated dilation, Acai polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Nov 2014 (estimated)
- 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.
The purpose of this study is to carry out a randomized double blind controlled trial in 30 male subjects to investigate the effect of acai consumption on acute changes in vascular function, and to other cardiovascular markers. As a secondary aim the study will allow us to characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 150g of acai fruit | Active comparator | Dietary Supplement: Acai puree, frozen blended it with banana150g of acai fruit in fruit smoothie form |
| Placebo control | Placebo comparator | Dietary Supplement: Control Macronutrient matchedThe control will be a smoothie-like drink matched for major macro- and micro-nutrients |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male, 30-65 aged, BMI 25-35 kg/m2, Cholesterol <8 mmol/l.
Key exclusion criteria (1 listed)
- Female, BMI <25 or >35 kg/m2, Cholesterol >8mmol l-1, elevated fasting blood sugar > 6.5 mmols l-1 , elevated systolic blood pressure >150 mmHg, history of stroke or heart attack within the previous 12 months, current smoking, taking lipid lowering, blood pressure lowering or anti-blood clotting medication or taking micronutrient supplements.
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 puree, frozen blended it with banana150g of acai fruit, frozen blended it with banana. | Dietary supplement | 150g of acai fruit |
| Control Macronutrient matchedMacronutrient matched control in water and also prepared with banana. | Dietary supplement | Placebo control |
Primary outcome
Flow-mediated dilation
Time frame: Change from baseline to 2h
1 secondary outcome
plasma polyphenol metabolites
Time frame: Change from baseline to 24h
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 30 May 2016.
- Derived from this study: PubMed 27680990Alqurashi RM, Galante LA, Rowland IR, Spencer JP, Commane DM. Consumption of a flavonoid-rich acai meal is associated with acute improvements in vascular function and a reduction in total oxidative status in healthy overweight men. Am J Clin Nutr. 2016 Nov;104(5):1227-1235. doi: 10.3945/ajcn.115.128728. Epub 2016 Sep 28.
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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.
Daniel Commane, PhD principal investigator
University of Reading
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 puree, frozen blended it with banana in people with Cardiovascular Diseases, run by University of Reading 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 1 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 30 May 2016. 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. Some participants in this study may receive a placebo. 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?
Flow-mediated dilation (time frame: Change from baseline to 2h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292329, which also lists 1 linked publication.
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 30 May 2016.