Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-01-22 @ 1:20 PM
Study NCT ID:
NCT06540118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2024-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Is Medicine for Patients With Heart Failure
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Food Is Medicine for Patients With Heart Failure
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
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:
This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index."
Detailed Description:
This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. Sixty adults with heart failure will be recruited from the San Diego and San Francisco Bay Area of California. They will be randomly assigned to two groups: 1) a group that receives 15 "medically tailored meals" plus snacks each week for 12 weeks, 2) a group that receives 14 "medically tailored meals" each week for 12 weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index". Many other secondary outcomes will be assessed including both qualitative factors (e.g., satisfaction, preferences, adherence) and quantitative clinically measures (e.g., blood cholesterol, blood pressure, weight).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: