Vis Pre Surgery Medical Food Validation Study

NCT07359222 | Terminated Early Phase 1

• 1 other identifier: JSSMC/IEC/18122023/20
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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 operative nausea and vomiting, decrease wound healing time, decrease length of hospital stay and readmittance and surgical mortality.

Conditions

Pre-surgical Anxiety; Blood Glucose Concentration; Blood Cortisol Levels; Electrolyte Levels; HbA1c; Surgical Infections; Wound Healing Time; Hospital Stay Time; Readmittance Rate; Mortality

Keywords

Medical food; Pre-surgical medical food

Outcome Measures

Primary Outcomes (1)

• Adverse events attributable to the study product

  Enrollment to 90 day follow up

Secondary Outcomes (3)

• 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 Outcomes (6)

• Blood glucose concentration

  Pre-op, peri-op, 24 hours post op, 48 hours post op

• HbA1c

  Pre-op and 90 days post-op.

• Electrolytes

  1 Day Post-op

Study Arms (2)

No-treatment control

NO INTERVENTION

Usual care

Vis Pre-Surgery

EXPERIMENTAL

Received Vis Pre-Surgery drink

Other: Pre-surgical medical food

Interventions

Pre-surgical medical food OTHER

Vis Pre-Surgery Medical Food

Vis Pre-Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TM Nutrition LLC: lead
• National University of Natural Medicine: collaborator

Study Sites (1)

JSS Medical College

Mysuru, India

Location

Study Officials

• Thea Marx, ND

  TM Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 22, 2026
• Study Start: April 9, 2024
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)