Optimization of Diet Before Surgery (OptiSurg) (OptiSurg)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Time Restricted Feeding
• Intervention / Treatment: Behavioral: Standard dietary advices; Behavioral: Time restricted feeding

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alban Longchamp, MD, PhD; Phone Number: +41 79 556 55 10; Email: alban.longchamp@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Contact: Alban Longchamp, M.D., Ph.D.; Phone Number: +41 79 556 55 10; Email: alban.longchamp@chuv.ch
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Brigham and Women's Hospital
      • Contact: C. Keith Ozaki, M.D.; Phone Number: 857-307-1920; Email: ckozaki1@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard dietary advices	Behavioral: Standard dietary advices; Participants will be given standard dietary advices, as recommended by the international nutrition guidelines, and thus are not different from common clinical practice.
Experimental: Time restricted feeding	Behavioral: Time restricted feeding; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.	Safety of TRF before vascular surgery	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	Improvement in limb perfusion measured as an increase in the reported index	1 month
Change in weight [gram]		1 month
Change in BMI [kg/m^2]		1 month
Change in total cholesterol levels [mg/dl]		1 month
Change in LDL cholesterol levels [mg/dl]		1 month
Change in HDL cholesterol levels [mg/dl]		1 month
Change in triglyceride levels [mg/dl]		1 month
Change in glycemia [mmol/L]		1 month
Change in insulin levels [pmol/L]		1 month
Change in HbA1c levels [%]		1 month
Adherence to TRF intervention	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.	1 month
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

Other Outcome Measures

Outcome Measure	Time Frame
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
Change in interferon gamma levels [pg/mL]	1, 2 days ans 1 month
Change in cortisol levels [nmol/L]	1, 2 days ans 1 month
Change in thyroid stimulating hormone levels [mIU/L]	1, 2 days ans 1 month
Change in triiodothyronine levels [nmol/L]	1, 2 days ans 1 month
Change in thyroxine levels [μg/d]	1, 2 days ans 1 month
Change in circulating hydrogen sulphide levels	1, 2 days ans 1 month
Change in circadian hormone secretion	1, 2 days ans 1 month
Change in gut microbiome	1, 2 days ans 1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019-02483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No