Status:
COMPLETED
Dietary Intervention in Persons With Metabolic Syndrome
Lead Sponsor:
Martha Biddle
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular ...
Detailed Description
SPECIFIC AIMS An estimated 47 million Americans have been diagnosed with metabolic syndrome. Glucose intolerance, abdominal obesity, hypertension and abnormal lipid profile are the identified traits o...
Eligibility Criteria
Inclusion
- Subjects will be individuals who have a diagnosis of metabolic syndrome without overt CVD as defined by the National Cholesterol Education Program (NCEP) as evidenced by having at least 3 of the 5 following conditions:
- Hypertension defined as SBP \>130mmHg and diastolic \>85mmHg
- Abdominal obesity with a waist circumference greater than 88cm in women and greater than 102 cm in men
- Triglycerides level greater than 150mg/dL
- HDL levels less than 50mg/dL in women and less than 40mg/dL in men
- Fasting glucose level greater than 100mg/dL Additional inclusion criteria include the ability to read and speak English, and have no cognitive impairment that precludes giving informed consent or ability to follow protocol instructions.
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Exclusion
- Subjects will be excluded from the study if they: a) are less than 21 years of age; b) have a terminal illness; c) have impaired cognition; d) have a strong dislike, or have a potential food-drug interaction to V8® Low Sodium 100% vegetable juice; or e) co-existing illness documented in the medical record or self-reported associated with systemic inflammation (e.g. rheumatoid arthritis, acute systemic infection).
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Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2021
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03836651
Start Date
December 1 2018
End Date
September 23 2021
Last Update
March 10 2022
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536