Pre-surgical AnxietyEarly Phase 1NCT07359222
Vis Pre Surgery Medical Food Validation Study
A Early Phase 1 study testing Pre-surgical medical food in people with Pre-surgical Anxiety and Blood Glucose Concentration, run by TM Nutrition LLC at 1 site in India.
Trial summary
A pre-market, confirmatory, prospective, interventional, clinical investigation to confirm the clinical safety and performance profile of Vis Pre-surgeryTM that the medical food will reduce pre and post-surgical complications including pre-operative anxiety, infections, hyperglycemia, adrenal insufficiency, post… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-surgical Anxiety, Blood Glucose Concentration, Blood Cortisol Levels
- What is being tested?
- Pre-surgical medical food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteIndia
- Study dates
- 9 Apr 2024to 4 Jul 2024
- Phase
- Early Phase 1
- 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
- adults (≥18 years) scheduled for elective abdominal, cardiac/thoracic, gynecological, or orthopedic surgery
Who cannot join
- kidney or liver disease, participation in a different clinical investigation that may affect the safety or performance of the investigation, being employees or family members of anyone involved in the investigation, and any other condition or treatment making a subject unsuitable for participation as judged by the Principal Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation to Validate the Safety and Efficacy of a Nutritional Medical Food Utilized Prior to Surgery to Reduce Post-surgical Complications.
A pre-market, confirmatory, prospective, interventional, clinical investigation to confirm the clinical safety and performance profile of Vis Pre-surgeryTM that the medical food will reduce pre and post-surgical complications including pre-operative anxiety, infections, hyperglycemia, adrenal insufficiency, post operative nausea and vomiting, decrease wound healing time, decrease length of hospital stay and readmittance and surgical mortality.
Read the detailed description
In the US alone, 48 million surgeries are performed: 310 million worldwide. Surgical site infections are the most prevalent and deadly post-surgery infection leading to an average of 6% of readmissions costing $10 billion dollars and 400,000 extra hospital days each year. If a surgical site infection occurs, the patient is 42% more likely to die following surgery. If that patient is a diabetic their chance of death increases by five times. Current protocol accepts surgical complications such as infections as known issues that are treated with antibiotic prior to surgery. Surgeons and hospital administrators need a way to affect a positive change in outcomes that augments current procedure and enhances positive outcomes including lowering surgical costs, reducing readmissions, improving hospital scorecards, and increasing survival.
VIS Pre-surgery addresses the specific metabolic and biochemical needs of an adult surgery patient in stress response. Support of these processes with carefully calibrated nutrient therapy reduces the risk of a patient succumbing to infections, especially surgical site infections, urinary tract infections and pneumonia. Product mechanism of action promotes balance of blood sugar levels, an important driver in the infection process while supporting critical immune system requirements to prevent tissue degradation.
This is a pre-market, safety, efficacy, validation clinical investigation to confirm the clinical safety and performance profile of VIS Pre-surgeryTM i. e that the medical food decreases pre-and post-surgical complications while reducing length of hospital stay, readmittance and mortality from surgery with no side effects.
The product is a FDA Medical Food formulated from GRAS (Generally Regarded As Safe) ingredients. The second aspect of the intended purpose (claim) of the medical food is currently supported by the specifications of the individual ingredients. This as clinical claim that can give clinical benefit by applying the cellular method of action for each nutrient, trace mineral and complex carbohydrate.
Patients who are scheduled for elective invasive surgery of upper, lower or cardiothoracic surgery will be asked to participate in the investigation by ingesting VIS Pre-surgery powder dissolved in water the evening prior to surgery at bedtime and again at 4 hours prior to scheduled surgery. Patients will be asked to complete questionnaires, provide blood samples prior to, during and post operatively, submit to abdominal ultrasound, observation and answer questions from coordinators.
Additional data points will be extrapolated from the collection of routine data such as hospital stay time, readmittance and mortality.
Patients will be identified by the PI and Co PIs.
- Conditions
- Pre-surgical Anxiety, Blood Glucose Concentration, Blood Cortisol Levels, Electrolyte Levels, HbA1c, Surgical Infections
- Being tested
- Pre-surgical medical food
- Keywords
- Medical food, Pre-surgical medical food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-surgical medical foodOther
Vis Pre-Surgery Medical Food
| Study group | Role | What they receive |
|---|---|---|
| No-treatment control | No intervention | Usual care |
| Vis Pre-Surgery | Experimental | Received Vis Pre-Surgery drink Receives: Other: Pre-surgical medical food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events attributable to the study product
Measured: Enrollment to 90 day follow up
Secondary outcomes (3)
Postoperative nausea and vomiting (PONV) incidence
Measured: From enrollment to 48 hours post-op
30-day hospital readmission
Measured: From enrollment to 30 days post-op
Post-operative infections
Measured: From enrollment to 90 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start9 Apr 2024
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Why it stopped: Frustrations around administrative issues at the study site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-surgical AnxietyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- TM Nutrition LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University of Natural Medicine
- Responsible party
- Sponsor
- Investigators
- Thea Marx, ND, Principal investigator, TM Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359222
- Sponsor's protocol ID
- JSSMC/IEC/18122023/20
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Validate the Safety and Efficacy of a Nutritional Medical Food Utilized Prior to Surgery to Reduce Post-surgical Complications.
- ClinicalTrials.gov ID
- NCT07359222
- Acronym / sponsor ID
- JSSMC/IEC/18122023/20
- Conditions
- Pre-surgical Anxiety, Blood Glucose Concentration, Blood Cortisol Levels, Electrolyte Levels, HbA1c, Surgical Infections
- Keywords
- Medical food, Pre-surgical medical food
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Frustrations around administrative issues at the study site.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- TM Nutrition LLCIndustry (pharma, biotech, devices)
- Collaborators
- National University of Natural Medicine
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 22 Jan 2026 (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.
A pre-market, confirmatory, prospective, interventional, clinical investigation to confirm the clinical safety and performance profile of Vis Pre-surgeryTM that the medical food will reduce pre and post-surgical complications including pre-operative anxiety, infections, hyperglycemia, adrenal insufficiency, post operative nausea and vomiting, decrease wound healing time, decrease length of hospital stay and readmittance and surgical mortality.
Detailed description
In the US alone, 48 million surgeries are performed: 310 million worldwide. Surgical site infections are the most prevalent and deadly post-surgery infection leading to an average of 6% of readmissions costing $10 billion dollars and 400,000 extra hospital days each year. If a surgical site infection occurs, the patient is 42% more likely to die following surgery. If that patient is a diabetic their chance of death increases by five times. Current protocol accepts surgical complications such as infections as known issues that are treated with antibiotic prior to surgery. Surgeons and hospital administrators need a way to affect a positive change in outcomes that augments current procedure and enhances positive outcomes including lowering surgical costs, reducing readmissions, improving hospital scorecards, and increasing survival.
VIS Pre-surgery addresses the specific metabolic and biochemical needs of an adult surgery patient in stress response. Support of these processes with carefully calibrated nutrient therapy reduces the risk of a patient succumbing to infections, especially surgical site infections, urinary tract infections and pneumonia. Product mechanism of action promotes balance of blood sugar levels, an important driver in the infection process while supporting critical immune system requirements to prevent tissue degradation.
This is a pre-market, safety, efficacy, validation clinical investigation to confirm the clinical safety and performance profile of VIS Pre-surgeryTM i. e that the medical food decreases pre-and post-surgical complications while reducing length of hospital stay, readmittance and mortality from surgery with no side effects.
The product is a FDA Medical Food formulated from GRAS (Generally Regarded As Safe) ingredients. The second aspect of the intended purpose (claim) of the medical food is currently supported by the specifications of the individual ingredients. This as clinical claim that can give clinical benefit by applying the cellular method of action for each nutrient, trace mineral and complex carbohydrate.
Patients who are scheduled for elective invasive surgery of upper, lower or cardiothoracic surgery will be asked to participate in the investigation by ingesting VIS Pre-surgery powder dissolved in water the evening prior to surgery at bedtime and again at 4 hours prior to scheduled surgery. Patients will be asked to complete questionnaires, provide blood samples prior to, during and post operatively, submit to abdominal ultrasound, observation and answer questions from coordinators.
Additional data points will be extrapolated from the collection of routine data such as hospital stay time, readmittance and mortality.
Patients will be identified by the PI and Co PIs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-treatment control | No intervention | –Usual care |
| Vis Pre-Surgery | Experimental | Other: Pre-surgical medical foodReceived Vis Pre-Surgery drink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults (≥18 years) scheduled for elective abdominal, cardiac/thoracic, gynecological, or orthopedic surgery
Key exclusion criteria (1 listed)
- kidney or liver disease, participation in a different clinical investigation that may affect the safety or performance of the investigation, being employees or family members of anyone involved in the investigation, and any other condition or treatment making a subject unsuitable for participation as judged by the Principal Investigator
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 |
|---|---|---|
| Pre-surgical medical foodVis Pre-Surgery Medical Food | Other | Vis Pre-Surgery |
Primary outcome
Adverse events attributable to the study product
Time frame: Enrollment to 90 day follow up
3 secondary outcomes
Postoperative nausea and vomiting (PONV) incidence
Time frame: From enrollment to 48 hours post-op
30-day hospital readmission
Time frame: From enrollment to 30 days post-op
Post-operative infections
Time frame: From enrollment to 90 day follow up
Results and safety
The study was stopped early (reason given: Frustrations around administrative issues at the study site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Thea Marx, ND principal investigator
TM Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pre-surgical medical food in people with Pre-surgical Anxiety and Blood Glucose Concentration, run by TM Nutrition LLC at 1 site in India.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Frustrations around administrative issues at the study site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events attributable to the study product (time frame: Enrollment to 90 day follow up). 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 22 Jan 2026.