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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02292329
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: Acai puree, frozen blended it with banana Dietary Supplement: Control Macronutrient matched Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Cardiovascular Benefits of Acai in Volunteers at Risk of Metabolic Syndrome.
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 150g of acai fruit
150g of acai fruit in fruit smoothie form
Dietary Supplement: Acai puree, frozen blended it with banana
150g of acai fruit, frozen blended it with banana.

Placebo Comparator: Placebo control
The control will be a smoothie-like drink matched for major macro- and micro-nutrients
Dietary Supplement: Control Macronutrient matched
Macronutrient matched control in water and also prepared with banana.




Primary Outcome Measures :
  1. Flow-mediated dilation [ Time Frame: Change from baseline to 2h ]

Secondary Outcome Measures :
  1. plasma polyphenol metabolites [ Time Frame: Change from baseline to 24h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292329


Locations
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United Kingdom
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Investigators
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Principal Investigator: Daniel Commane, PhD University of Reading
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeremy Paul Edward Spencer, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT02292329    
Other Study ID Numbers: AF1UReading
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016
Keywords provided by Jeremy Paul Edward Spencer, University of Reading:
flow-mediated dilation
Acai polyphenols
Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Nutrients
Growth Substances
Physiological Effects of Drugs