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Search / Trial NCT03836651

Dietary Intervention in Persons With Metabolic Syndrome

Launched by MARTHA BIDDLE · Feb 8, 2019

Trial Information

Current as of July 06, 2025

Completed

Keywords

Oxidative Stress Metabolic Syndrome Inflammation

ClinConnect Summary

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 of metabolic syndrome. Metabolic syndrome is a grouping of conditions that collectively are associated with a two-fold risk of cardiovascular disease (CVD). Inflammation and oxidative stress are contributing factors for the development of atherosclerotic plaque in CVD and are the initial pathological responses for each of the abnormal conditions associated with metabolic syndrome. Consequently, ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria: 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:
  • 1. Hypertension defined as SBP \>130mmHg and diastolic \>85mmHg
  • 2. Abdominal obesity with a waist circumference greater than 88cm in women and greater than 102 cm in men
  • 3. Triglycerides level greater than 150mg/dL
  • 4. HDL levels less than 50mg/dL in women and less than 40mg/dL in men
  • 5. 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 Criteria: 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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About Martha Biddle

Martha Biddle is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapies and evidence-based practices, the organization collaborates with healthcare professionals, researchers, and regulatory bodies to design and execute clinical trials that meet the highest standards of scientific rigor and ethical integrity. Through its strategic partnerships and a patient-centered approach, Martha Biddle aims to contribute to the development of groundbreaking treatments across a variety of therapeutic areas, ultimately enhancing the quality of care for diverse populations.

Locations

Lexington, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Martha Biddle, PhD

Principal Investigator

University of Kentucky

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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