SurgeryOptiSurgNCT04627688
Optimization of Diet Before Surgery (OptiSurg)
A study testing Time restricted feeding and Standard dietary advices in people with Surgery and Time Restricted Feeding, run by Centre Hospitalier Universitaire Vaudois at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Time Restricted Feeding
- What is being tested?
- Time restricted feeding and Standard dietary advices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Jan 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
C. Keith Ozaki, M.D., 857-307-1920, ckozaki1@bwh.harvard.edu
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Alban Longchamp, M.D., Ph.D., +41 79 556 55 10, alban.longchamp@chuv.ch
About this study
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
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
- Being tested
- Time restricted feeding, Standard dietary advices
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
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 advicesBehavioural
Participants will be given standard dietary advices, as recommended by the international nutrition guidelines, and thus are not different from common clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Standard dietary advices | Active comparator | Not described Receives: Behavioral: Standard dietary advices |
| Time restricted feeding | Experimental | Not described Receives: Behavioral: Time restricted feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.
Safety of TRF before vascular surgery
Measured: 1 month
Secondary outcomes (14)
Length of Stay [days]
Measured: 1 month
Change in systolic and diastolic blood pressure [mmHg]
Measured: 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
Measured: 1 month
Change in weight [gram]
Measured: 1 month
Change in BMI [kg/m^2]
Measured: 1 month
Change in total cholesterol levels [mg/dl]
Measured: 1 month
Change in LDL cholesterol levels [mg/dl]
Measured: 1 month
Change in HDL cholesterol levels [mg/dl]
Measured: 1 month
Change in triglyceride levels [mg/dl]
Measured: 1 month
Change in glycemia [mmol/L]
Measured: 1 month
Change in insulin levels [pmol/L]
Measured: 1 month
Change in HbA1c levels [%]
Measured: 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.
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start25 Jan 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alban Longchamp, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627688
- Sponsor's protocol ID
- 2019-02483
- Other IDs
- 2019
- Acronym
- OptiSurg
- Status last verified
- Aug 2021
- First submitted
- 19 Oct 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04627688
- Acronym / sponsor ID
- OptiSurg / 2019-02483
- Conditions
- Surgery, Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dietary advices | Active comparator | Behavioral: Standard dietary advices |
| Time restricted feeding | Experimental | Behavioral: Time restricted feeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted feedingParticipants 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. | Behavioural | Time restricted feeding |
| Standard dietary advicesParticipants will be given standard dietary advices, as recommended by the international nutrition guidelines, and thus are not different from common clinical practice. | Behavioural | Standard dietary advices |
Primary outcome
Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.
Time frame: 1 month
Safety of TRF before vascular surgery
14 secondary outcomes
Length of Stay [days]
Time frame: 1 month
Change in systolic and diastolic blood pressure [mmHg]
Time frame: 1 month
Change in ankle and toe brachial index [0.2-1.4]
Time frame: 1 month
Change in weight [gram]
Time frame: 1 month
Change in BMI [kg/m^2]
Time frame: 1 month
Change in total cholesterol levels [mg/dl]
Time frame: 1 month
Change in LDL cholesterol levels [mg/dl]
Time frame: 1 month
Change in HDL cholesterol levels [mg/dl]
Time frame: 1 month
Change in triglyceride levels [mg/dl]
Time frame: 1 month
Change in glycemia [mmol/L]
Time frame: 1 month
Change in insulin levels [pmol/L]
Time frame: 1 month
Change in HbA1c levels [%]
Time frame: 1 month
Adherence to TRF intervention
Time frame: 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).
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Surgery
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted feeding and Standard dietary advices in people with Surgery and Time Restricted Feeding, run by Centre Hospitalier Universitaire Vaudois at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alban Longchamp, MD, PhD (+41 79 556 55 10, alban.longchamp@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.