Optimization of Diet Before Surgery (OptiSurg)

Not Applicable

• Conditions: Surgery; Time Restricted Feeding
• Interventions: Behavioral: Standard dietary advices; Behavioral: Time restricted feeding

• Registration Number: NCT04627688
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-13
• Study Start: 2021-01-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03
• Primary Completion: 2022-11-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dietary advices	Standard dietary advices	-
Time restricted feeding	Time restricted feeding	-

Primary Outcome Measures

Name	Time	Method
Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.	1 month	Safety of TRF before vascular surgery

Secondary Outcome Measures

Name	Time	Method
Change in BMI [kg/m^2]	1 month
Change in total cholesterol levels [mg/dl]	1 month
Change in HDL cholesterol levels [mg/dl]	1 month
Change in triglyceride levels [mg/dl]	1 month
Length of Stay [days]	1 month
Change in insulin levels [pmol/L]	1 month
Change in glycemia [mmol/L]	1 month
Change in HbA1c levels [%]	1 month
Change in weight [gram]	1 month
Change in LDL cholesterol levels [mg/dl]	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	Improvement in limb perfusion measured as an increase in the reported index
Time from randomization to the first occurrence of any of the following major thrombotic vascular events: MI (Myocardial infarction), ischemic stroke, CV (Cardiovascular) death, ALI (Acute limb ischemia), and major amputation or death (any cause).	1 year
Adherence to TRF intervention	1 month	Adherence will be determined using the smartphone app, by the number of days in which a participant will be adherent to logging and all caloric food items were contained within a 15-min buffer on each side of the selected eating window.

Trial Locations

Locations (2)

Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Vaud, Switzerland

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States