Optimization of Diet Before Surgery (OptiSurg)

Last updated: August 2, 2021
Sponsor: Centre Hospitalier Universitaire Vaudois
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Treatment

N/A

Clinical Study ID

NCT04627688
2019-02483
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 qualifyingrevascularization.
  • 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

Total Participants: 40
Study Start date:
January 25, 2021
Estimated Completion Date:
July 01, 2023

Connect with a study center

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Vaud 1011
    Switzerland

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

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