NCT02227628

Brief Summary

A human clinical consumption trial will be performed in volunteers with increased risk factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4, 8, and 12 weeks and a 24 hr urine collection on each blood draw day.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

June 4, 2014

Last Update Submit

October 14, 2016

Conditions

Cardiovascular DiseaseMetabolic SyndromeObesity

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in the levels of Inflammatory biomarkers in plasma or urine

    During each of the testing sessions, participants donated approximately 2 teaspoons of fasting venous blood (10 milliliters). All urine output for the 24 hours leading up to the baseline testing was collected. Inflammatory biomarkers in the plasma (hs-C-reactive protein(mg/L), interleukin-6(pg/ml), interleukin-1beta(pg/ml), Interferon-gamma(pg/ml), and Tumor necrosis factor-alpha(pg/ml)) and in the urine (8-isoprostane(ng/mmol creatinine) were measured by enzyme immunoassay using Cayman chemical kits (Ann Arbor, MI).

    baseline, 24 hours

Study Arms (2)

Sugary Beverage

PLACEBO COMPARATOR

Sugary Beverage

Dietary Supplement: Sugary Beverage

Acai beverage

EXPERIMENTAL

Acai Polyphenolics

Dietary Supplement: Acai polyphenolics

Interventions

Acai polyphenolicsDIETARY_SUPPLEMENT

Acai beverage was obtained from the Sambazon (San Clemente, CA).

Acai beverage
Sugary BeverageDIETARY_SUPPLEMENT

An equal amount of placebo juice comprised of artificially colored water containing sugar (5%), citric acid (0.01% to adjust the pH 3.8), and artificial colors (FD\&C Red 40 and Blue 1, Tetra Pak, Denten, TX) that was identical to the acai beverage.

Sugary Beverage

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated waist circumference: ≥102cm in men and ≥ 88 cm in women
  • Elevated triglycerides:≥ 150 mg/dL
  • Reduced HDL-C:\<40 mg/dL in men and \<50 mg/dL in women
  • Elevated blood pressure:≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure
  • Elevated fasting glucose:≥ 100 mg/dL

You may not qualify if:

  • History of any relevant acute cardiac event (myocardial infarction, episode of heart failure)
  • Recent (within 3 months) or recurrent hospitalizations
  • Drug treatment for type II diabetes
  • aspartate aminotransferase or alanine aminotransferase ≥ 2 times the upper limit of normal
  • Abuse of alcohol or substance, smoking, history of seizures, or other relevant ongoing or recurrent illness, liver or renal dysfunction, pregnancy (positive urine pregnancy test) or lactation, known allergy against any of the juices, known infection with hepatitis B, C, or HIV, intake of vasoactive drugs
  • Individuals participating in regular aerobic exercise training program (\>30 minutes, ≥ 3 times/wk)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise & Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&M University

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic SyndromeObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susanne Talcott, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

August 28, 2014

Study Start

April 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

US(1)