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Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome

NCT01010841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2012-01-12

No results posted yet for this study

Summary

The objective of this study was to investigate from 3 sites (University of Connecticut, University of Florida, and University of California, Irvine) whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve cardiometabolic risk factors in women with metabolic syndrome.

Conditions

Interventions

DIETARY_SUPPLEMENT

UltraMealPlus 360 (Medical food)

Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)

OTHER

Low-glycemic-load diet

Modified Mediterranean-style low-glycemic-load diet

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER

  • University of Connecticut

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • MetaProteomics LLC

    lead INDUSTRY

Principal Investigators

  • Robert H Lerman, MD/PhD · MetaProteomics LLC

  • Mark McIntosh, MD · University of Florida

  • Maria Luz Fernandez, PhD · University of Connecticut

  • Wadie Najm, PhD · University of California at Irvine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01010841 on ClinicalTrials.gov