Optimization of Diet Before Surgery (OptiSurg)
OptiSurg
1 other identifier
interventional
40
2 countries
2
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 diaries/questionnaires 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable surgery
Started Jan 2021
Typical duration for not_applicable surgery
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedStudy Start
First participant enrolled
January 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedAugust 3, 2021
August 1, 2021
1.8 years
October 19, 2020
August 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.
Safety of TRF before vascular surgery
1 month
Secondary Outcomes (14)
Length of Stay [days]
1 month
Change in systolic and diastolic blood pressure [mmHg]
1 month
Change in ankle and toe brachial index [0.2-1.4]
1 month
Change in weight [gram]
1 month
Change in BMI [kg/m^2]
1 month
- +9 more secondary outcomes
Other Outcomes (11)
Change in interleukin-6,-1, -10 levels [pg/ml]
1, 2 days ans 1 month
Change in tumor necrosis factor alpha levels [pg/mL]
1, 2 days ans 1 month
Change in transforming growth factor beta levels [ng/mL]
1, 2 days ans 1 month
- +8 more other outcomes
Study Arms (2)
Standard dietary advices
ACTIVE COMPARATORTime restricted feeding
EXPERIMENTALInterventions
Participants will be advised to eat only during a selected window of 8 hours, and no later than 4pm, with no advice on nutrition quality, quantity or caloric intake. The intervention will include no medication, no medical device, and will last for 2 weeks prior to surgery.
Participants will be given standard dietary advices, as recommended by the international nutrition guidelines, and thus are not different from common clinical practice.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Fontaine stage II peripheral artery disease planned for open femoral endarterectomy
- Body mass index ≥ 20 kg/m2
- Smartphone compatible with the app (iOS or Android systems)
- Hypertensive (or on 1 or more blood pressure lowering medication)
- Hypercholesterolemia (or on 1 or more lipid lowering medication)
You may not qualify if:
- Diabetes on insulin therapy or sulfonylureas
- Fontaine stage III and IV peripheral artery disease
- Prior revascularization on the index leg within 14 days of the qualifying revascularization.
- Major surgery in the past 3 months
- Myocardial infarction or revascularization (PTA, stent, CABG) in the past 3 months
- Major illness / fever over the previous month, active cancer
- On a diet / weight management or prior bariatric surgery
- Major mental illness, unable to give consent, inability to follow study procedures (language barrier, dementia)
- Current shift work or travel abroad planned in the next month
- Major sleep disorder
- Enrolled in another interventional clinical trial
- Ongoing pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 19, 2020
First Posted
November 13, 2020
Study Start
January 25, 2021
Primary Completion
November 1, 2022
Study Completion
July 1, 2023
Last Updated
August 3, 2021
Record last verified: 2021-08