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

Cardiovascular Diseases Clinical Trial

— AF1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292329
• Other study ID #: AF1UReading
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: May 27, 2016
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Acai puree, frozen blended it with banana
150g of acai fruit, frozen blended it with banana.
• Control Macronutrient matched
Macronutrient matched control in water and also prepared with banana.

Locations

Country	Name	City	State
United Kingdom	Hugh Sinclair Unit of Human Nutrition	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation		Change from baseline to 2h	No
Secondary	plasma polyphenol metabolites		Change from baseline to 24h	No