Absorption and Antioxidant Effects of Polyphenolics From Acai (NCT02227628) | Clinical Trial Compass
CompletedNot Applicable
Absorption and Antioxidant Effects of Polyphenolics From Acai
United States50 participantsStarted 2013-04
Plain-language 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.
Who can participate
Age range30 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
What they're measuring
1
Changes from baseline in the levels of Inflammatory biomarkers in plasma or urine