Optimization of Diet Before Surgery (OptiSurg)

NCT ID: NCT04627688

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2023-07-01

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.

Conditions

Surgery; Time Restricted Feeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard dietary advices

Group Type: ACTIVE_COMPARATOR

Standard dietary advices

Intervention Type: BEHAVIORAL

Participants will be given standard dietary advices, as recommended by the international nutrition guidelines, and thus are not different from common clinical practice.

Time restricted feeding

Group Type: EXPERIMENTAL

Time restricted feeding

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Alban Longchamp

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: NOT_YET_RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

United States; Switzerland

Central Contacts

Alban Longchamp, MD, PhD

Role: CONTACT

alban.longchamp@chuv.ch

+41 79 556 55 10

Facility Contacts

C. Keith Ozaki, M.D.

Role: primary

ckozaki1@bwh.harvard.edu

857-307-1920

Alban Longchamp, M.D., Ph.D.

Role: primary

alban.longchamp@chuv.ch

+41 79 556 55 10

Other Identifiers

2019-02483

Identifier Type: -

Identifier Source: org_study_id