Ignite Creation Date:
2024-05-05 @ 10:06 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01033513
Status:
COMPLETED
Last Update Posted:
2017-10-31
First Post:
2009-12-15
Brief Title:
SOS Nutrition Project
Sponsor:
University of North Carolina Charlotte
Organization:
University of North Carolina Charlotte
Study Overview
Official Title:
SOS Nutrition Project
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None