Status:
COMPLETED
Effects of Wine Grape Pomace Flour Used as a Dietary Supplement on Metabolic Syndrome Components
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Conditions:
Metabolic Syndrome X
Oxidative Stress
Eligibility:
MALE
30-65 years
Phase:
NA
Brief Summary
Lifestyle modifications, including healthy food intake, exercise, and suppression of tobacco smoking, constitute the most powerful tool to fight chronic diseases. Antioxidants and fiber, two component...
Detailed Description
A 16-week longitudinal intervention study. Males, 30-65 years of age, with at least one component of metabolic syndrome, were randomly assigned to either the intervention group or the control group. A...
Eligibility Criteria
Inclusion
- Subject who regularly consumed an omnivorous diet.
- Subjects that had at least one of the five components of metabolic syndrome.
Exclusion
- Subjects that were under treatment for diabetes mellitus, hypertension (\> 160/100) or dyslipidemia (hypertriglyceridemia\> 500 mg / dl, hypercholesterolemia\> 350 mg / dl)
- Subjects who consume drugs affecting lipid profile, blood pressure, metabolism of carbohydrates or the antioxidant capacity of plasma.
- Subjects with obesity, BMI \> 30
- Subjects who have had a cardiovascular event.
- Subjects with bariatric surgery
- Subjects with untreated thyroid disease, renal disease (serum creatinine\> 1.5 mg / dl), active liver disease, or other rheumatic disease that could alter the measurements.
- Subjects with chronic inflammatory diseases.
- Subjects that use of supplements containing antioxidants.
- Smoking more than 5 cigarettes per day
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02202863
Start Date
April 1 2013
End Date
September 1 2013
Last Update
July 29 2014
Active Locations (1)
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1
Centro de Nutricion Molecular y Enfermedades Cronicas, Pontificia Universidad Catolica de Chile
Santiago, Centro, Chile