Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04627688
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2020-10-19
Brief Title:
Optimization of Diet Before Surgery OptiSurg
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Optimization of Diet Before Surgery OptiSurg Effects of Time Restricted Feeding TRF Before Vascular Surgery - An Open-label Randomized Controlled Trial of TRF vs Regular Dietary Advices
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
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:
OptiSurg
Brief Summary:
The overarching goal of this project is to assess whether a controlled short-term Time restricted feeding TRF intervention leads to metabolic benefits improves recovery after vascular surgery and that TRF is safe Participants suffering from intermittent claudication Fontaine stage II peripheral artery disease PAD will be randomly assigned to a 2-week TRF or active control dietary advices before open surgical revascularization Prior to the surgery the investigators will assess the eating patterns of participants with an innovative smartphone application app which is less intrusive and more reliable than food diariesquestionnaires to assess eating behavior and patterns In the second part of the study the investigators will investigate whether a short term TRF intervention improves surgical recovery in the short-term 1 month primary endpoint and long-term optional up to 1 year as part of the routine clinical follow-up This proposal builds on established expertise in the biology of dietary intervention surgery and study of eating patterns in human
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None