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OpenTrials
Completed

NCT Number: NCT02292329

Cardiovascular Benefits of Acai Polyphenols 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.

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Key information

Conditions

Cardiovascular Diseases

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acai puree, frozen blended it with banana

Dietary Supplement

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

Control Macronutrient matched

Dietary Supplement

Macronutrient matched control in water and also prepared with banana.

Primary outcomes

  1. Flow-mediated dilation

    Time frame: Change from baseline to 2h

Secondary outcomes

  1. plasma polyphenol metabolites

    Time frame: Change from baseline to 24h

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

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

Acronym: AF1

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2014
Registry last updated
May 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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