Optimization of Diet Before Surgery (OptiSurg)

Surgery Clinical Trial

— OptiSurg  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627688
• Other study ID #: 2019-02483
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Alban Longchamp, MD, PhD
• Phone: +41 79 556 55 10
• Email: alban.longchamp[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery
• Time Restricted Feeding

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in interleukin-6,-1, -10 levels [pg/ml]		1, 2 days ans 1 month
Other	Change in tumor necrosis factor alpha levels [pg/mL]		1, 2 days ans 1 month
Other	Change in transforming growth factor beta levels [ng/mL]		1, 2 days ans 1 month
Other	Change in interferon gamma levels [pg/mL]		1, 2 days ans 1 month
Other	Change in cortisol levels [nmol/L]		1, 2 days ans 1 month
Other	Change in thyroid stimulating hormone levels [mIU/L]		1, 2 days ans 1 month
Other	Change in triiodothyronine levels [nmol/L]		1, 2 days ans 1 month
Other	Change in thyroxine levels [µg/d]		1, 2 days ans 1 month
Other	Change in circulating hydrogen sulphide levels		1, 2 days ans 1 month
Other	Change in circadian hormone secretion		1, 2 days ans 1 month
Other	Change in gut microbiome		1, 2 days ans 1 month
Primary	Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.	Safety of TRF before vascular surgery	1 month
Secondary	Length of Stay [days]		1 month
Secondary	Change in systolic and diastolic blood pressure [mmHg]		1 month
Secondary	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
Secondary	Change in weight [gram]		1 month
Secondary	Change in BMI [kg/m^2]		1 month
Secondary	Change in total cholesterol levels [mg/dl]		1 month
Secondary	Change in LDL cholesterol levels [mg/dl]		1 month
Secondary	Change in HDL cholesterol levels [mg/dl]		1 month
Secondary	Change in triglyceride levels [mg/dl]		1 month
Secondary	Change in glycemia [mmol/L]		1 month
Secondary	Change in insulin levels [pmol/L]		1 month
Secondary	Change in HbA1c levels [%]		1 month
Secondary	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
Secondary	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