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How Maxvida High-Protein Formula Affects Adults Needing Tube Feeding with the Same Calories

An Open-label Clinical Study to evaluate the safety and gastrointestinal tolerance (Product Compliance) of Maxvida High Protein in adults requiring isocaloric formula for enteral tube feeding. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068511
Enrollment
30
Registered
2024-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E898- Other postprocedural endocrine andmetabolic complications and disorders

Interventions

Intervention1: Maxvida High protein: Maxvida high protein is a specially formulated protein powder supplement with high protein high fiber specialized adult nutrition supplement with 33 key nutrients

Sponsors

Signtura Health and nutrition
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Ready to Sign informed consent form or informed consent form signed by legally acceptable representatives. 2.Aged more than 18 years 3.Gender: Male & Female. 4.Hospitalized patients requiring isocaloric formula for enteral feeding. 5.Can tolerate enteral tube feeding. 6.Estimated duration of Hospital stays equal to or greater than 2 days.

Exclusion criteria

Exclusion criteria: 1.Receiving tube feeding prior to hospitalization. 2.Patients less than 18 years of age. 3.Patients having allergy to constituents of Maxvida High Protein. 4.Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.

Design outcomes

Primary

MeasureTime frame
1. To study Continuous GI tolerance (Product Compliance): a. Diarrhea free day b. Stomach irritation c. Regurgitation d. Abdominal bloating e. Vomiting f. GRV less than 500 ml (GRV to be checked at 0730 hours, 0900 hours, 1530 hours, 1700 hours)Timepoint: end of hospitalization or 5 days whichever earlier.

Secondary

MeasureTime frame
1.To Evaluate Change in weight (kg) during pre and post intervention of the study product 2.To Evaluate Change in serum albumin during pre and post intervention of the study product 3.Adverse event and serious adverse event monitoring based on clinical and laboratory AE’s.Timepoint: end of hospitalization or 5 days whichever earlier.

Countries

India

Contacts

Public ContactDr Punit Srivastava

Mediception Science Pvt Ltd.

punit@mediception.com8586928449

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026