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Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome (AF1)

Primary Purpose

Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acai puree, frozen blended it with banana
Control Macronutrient matched
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Diseases focused on measuring flow-mediated dilation, Acai polyphenols

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male, 30-65 aged, BMI 25-35 kg/m2, Cholesterol <8 mmol/l.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hugh Sinclair Unit of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

150g of acai fruit

Placebo control

Arm Description

150g of acai fruit in fruit smoothie form

The control will be a smoothie-like drink matched for major macro- and micro-nutrients

Outcomes

Primary Outcome Measures

Flow-mediated dilation

Secondary Outcome Measures

plasma polyphenol metabolites

Full Information

First Posted
September 24, 2014
Last Updated
May 27, 2016
Sponsor
University of Reading
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1. Study Identification

Unique Protocol Identification Number
NCT02292329
Brief Title
Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome
Acronym
AF1
Official Title
Cardiovascular Benefits of Acai in Volunteers at Risk of Metabolic Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
flow-mediated dilation, Acai polyphenols

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
150g of acai fruit
Arm Type
Active Comparator
Arm Description
150g of acai fruit in fruit smoothie form
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
The control will be a smoothie-like drink matched for major macro- and micro-nutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
Acai puree, frozen blended it with banana
Intervention Description
150g of acai fruit, frozen blended it with banana.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Macronutrient matched
Intervention Description
Macronutrient matched control in water and also prepared with banana.
Primary Outcome Measure Information:
Title
Flow-mediated dilation
Time Frame
Change from baseline to 2h
Secondary Outcome Measure Information:
Title
plasma polyphenol metabolites
Time Frame
Change from baseline to 24h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male, 30-65 aged, BMI 25-35 kg/m2, Cholesterol <8 mmol/l. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Commane, PhD
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hugh Sinclair Unit of Human Nutrition
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27680990
Citation
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.
Results Reference
derived

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Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome

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