Vis Pre Surgery Medical Food Validation Study

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.

Study Overview

• Status: Terminated
• Conditions: Mortality; HbA1c; Blood Glucose Concentration; Pre-surgical Anxiety; Blood Cortisol Levels; Electrolyte Levels; Surgical Infections; Wound Healing Time; Hospital Stay Time; Readmittance Rate
• Intervention / Treatment: Other: Pre-surgical medical food

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• India
  • Mysuru, India
    • JSS Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults (≥18 years) scheduled for elective abdominal, cardiac/thoracic, gynecological, or orthopedic surgery

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No-treatment control; Usual care
Experimental: Vis Pre-Surgery; Received Vis Pre-Surgery drink	Other: Pre-surgical medical food; Vis Pre-Surgery Medical Food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events attributable to the study product	Enrollment to 90 day follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Postoperative nausea and vomiting (PONV) incidence	From enrollment to 48 hours post-op
30-day hospital readmission	From enrollment to 30 days post-op
Post-operative infections	From enrollment to 90 day follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose concentration		Pre-op, peri-op, 24 hours post op, 48 hours post op
HbA1c		Pre-op and 90 days post-op.
Electrolytes	sodium, potassium, chloride, calcium, magnesium	1 Day Post-op
Stress hormone	Cortisol	1 Day Pre-op and 1 Day post-op
Post-op pain	Scale from 0-10	1 Day Post-op
Pre-op emotional state	A single-choice between calm, relaxed, content, tense, worried, upset	1 Day Pre-op

Collaborators and Investigators

• Sponsor: TM Nutrition LLC
• Collaborators: National University of Natural Medicine
• Investigators: Principal Investigator: Thea Marx, ND, TM Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Actual): July 4, 2024
• Study Completion (Actual): July 4, 2024

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Medical food; Pre-surgical medical food
• Other Study ID Numbers: JSSMC/IEC/18122023/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No