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SOS Nutrition Project

NCT01033513 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2017-10-31

No results posted yet for this study

Summary

Many older people experience hyperlipidemia and hypertension, but, to date, there is little information regarding whether or not medical nutrition therapy (MNT) or therapeutic meals have an independent or joint beneficial impact on older people with these diagnoses. This report describes a clinical trial in which the investigators directly examined these issues. Two key clinical outcome measures include changes in diastolic blood pressure and total fasting serum cholesterol. In addition to these clinical outcome measures the investigators collected health related quality of life data and data that permitted cost-effectiveness analyses.

The investigators hypothesized that MNT and therapeutic meals would each lead to lower total fasting serum cholesterol and lower diastolic blood pressure after the 52-week trial, in comparison to individuals who received standard support (commonly available literature on how to manage their disease). The investigators also hypothesized that MNT plus therapeutic meals would be especially beneficial because of their synergistic effects on the clinical outcomes. Although the investigators established no specific hypotheses regarding the potential impact of MNT or therapeutic meals on cost of care and quality adjusted life years, the investigators were interested in whether MNT or therapeutic meals would be associated with these two measures.

Conditions

Sponsors & Collaborators

  • Administration on Aging, United States

    collaborator FED

  • Mecklenburg County Department of Social Services

    collaborator UNKNOWN

  • University of North Carolina, Charlotte

    lead OTHER

Principal Investigators

  • William J McAuley, PhD · George Mason University

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Completion
2006-09-22

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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 NCT01033513 on ClinicalTrials.gov