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Effect of Novel High Dissolving Transitional Foods

NCT06522958 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-01

No results posted yet for this study

Summary

This is a prospective comparative study, where patients who meet inclusion criteria undergoing a craniofacial procedure will either be provided with novel high dissolving transitional foods for use in the post-operative period (Intervention Group) or will not be provided the food and will proceed as per current standard of care (Standard of Care Group). Both groups will be followed pre-operatively at time of pre-operative visit, and will be followed in the post-operative period, with two visits at 1 and 3 weeks post-operatively, respectively.

Conditions

  • Craniofacial Surgery

Interventions

DIETARY_SUPPLEMENT

High Dissolving Transitional Food

Transitional foods are solid foods that rapidly change texture in the presence of moisture (e.g., water or saliva) or temperature change. Duration of consumption of the investigational agent will include the time of the surgery until the second post-operative evaluation. This is estimated to be approximately 1-2 months in total.

Sponsors & Collaborators

Principal Investigators

  • Roberto Flores, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2027-02-28
Completion
2027-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06522958 on ClinicalTrials.gov