Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome
AF1
1 other identifier
interventional
23
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Sep 2014
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
November 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 30, 2016
May 1, 2016
6 months
September 24, 2014
May 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow-mediated dilation
Change from baseline to 2h
Secondary Outcomes (1)
plasma polyphenol metabolites
Change from baseline to 24h
Study Arms (2)
150g of acai fruit
ACTIVE COMPARATOR150g of acai fruit in fruit smoothie form
Placebo control
PLACEBO COMPARATORThe control will be a smoothie-like drink matched for major macro- and micro-nutrients
Interventions
150g of acai fruit, frozen blended it with banana.
Macronutrient matched control in water and also prepared with banana.
Eligibility Criteria
You may qualify if:
- Male, 30-65 aged, BMI 25-35 kg/m2, Cholesterol \<8 mmol/l.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, RG6 6AP, United Kingdom
Related Publications (1)
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.
PMID: 27680990DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Commane, PhD
University of Reading
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 24, 2014
First Posted
November 17, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 30, 2016
Record last verified: 2016-05