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

NCT ID: NCT02292329

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Keywords

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flow-mediated dilation Acai polyphenols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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150g of acai fruit

150g of acai fruit in fruit smoothie form

Group Type ACTIVE_COMPARATOR

Acai puree, frozen blended it with banana

Intervention Type DIETARY_SUPPLEMENT

150g of acai fruit, frozen blended it with banana.

Placebo control

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

Group Type PLACEBO_COMPARATOR

Control Macronutrient matched

Intervention Type DIETARY_SUPPLEMENT

Macronutrient matched control in water and also prepared with banana.

Interventions

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Acai puree, frozen blended it with banana

150g of acai fruit, frozen blended it with banana.

Intervention Type DIETARY_SUPPLEMENT

Control Macronutrient matched

Macronutrient matched control in water and also prepared with banana.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Commane, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27680990 (View on PubMed)

Other Identifiers

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AF1UReading

Identifier Type: -

Identifier Source: org_study_id