High Dissolving Food for Facial Reconstruction

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Tube feeding, Speech restrictions, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

160 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High Dissolving Transitional Food for facial reconstruction?

The research suggests that transitional foods, like the Savorease cracker, dissolve well in the mouth, which can be beneficial for people who have difficulty chewing or swallowing. This property might help improve nutrition and mealtime satisfaction for those on modified texture diets, potentially aiding recovery in facial reconstruction. ^{1 2 3 4 5}

Is High Dissolving Food for Facial Reconstruction safe for humans?

The safety of texture-modified diets (TMDs), which are similar to High Dissolving Food, has been evaluated for people with swallowing difficulties. These diets are designed to be safe for swallowing, but they may have risks related to nutrition intake, as they can lead to lower energy and protein consumption compared to regular diets. ^{6 7 8 9 10}

How does the High Dissolving Food treatment for facial reconstruction differ from other treatments?

The High Dissolving Food treatment is unique because it uses transitional foods that dissolve easily in the mouth, which can be beneficial for individuals with difficulties in chewing or swallowing. This approach focuses on optimizing eating pleasure and nutrition by using foods that dissolve quickly, unlike traditional solid foods that may require more effort to consume. ^{1 2 11 12 13}

What is the purpose of this trial?

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.

Research Team

Roberto Flores, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for patients undergoing craniofacial procedures. Participants will be those who meet specific criteria to ensure they are suitable for the study, but detailed inclusion and exclusion criteria have not been provided.

Inclusion Criteria

I am scheduled for surgery related to my cleft/craniofacial condition this year.

Patients who eat fully by mouth (PO)

Patients who adhered to scheduling protocols and attended all necessary pre- and post-operative visits

Exclusion Criteria

Patients with diagnosed allergies to ingredients in Savorease Therapeutic Foods

Patients/caregivers unable to participate in pre- and post-operative protocoled visits

I use a tube for my main source of eating and drinking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants are assessed at the pre-operative visit, including wound examination and weight measurement

Baseline

1 visit (in-person)

Post-operative

Participants receive either novel high dissolving transitional foods or standard care, with follow-up visits to assess wound issues and weight

3 weeks

2 visits (in-person) at 1 and 3 weeks post-op

Follow-up

Participants are monitored for safety and effectiveness, including 30-day readmission rate

4 weeks

Treatment Details

Interventions

• High Dissolving Transitional Food

Trial Overview The study is testing high dissolving transitional foods in patients after facial reconstruction surgery. One group receives these novel foods post-operation, while the other follows standard care without them. Their recovery is compared at 1 and 3 weeks post-surgery.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients randomized to the intervention group will receive a high dissolving transitional food product.

Group II: Standard of Care Group Active Control 1 Intervention

Patients randomized to the standard of care group will not receive a high dissolving transitional food product.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Behavior of Transitional-State Foods Under Varying Oral Conditions. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

[Effects of a diet with products in texture modified diets in elderly ambulatory patients]. [2013]

3. Spain pubmed.ncbi.nlm.nih.gov

[Texture-modified foods; from grounding or dehydration to current products]. [2014]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Texture-Modified Diets, Nutritional Status and Mealtime Satisfaction: A Systematic Review. [2023]

5. France pubmed.ncbi.nlm.nih.gov

Texture-Modified Diet for Improving the Management of Oropharyngeal Dysphagia in Nursing Home Residents: An Expert Review. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Implementation Strategies for the International Dysphagia Diet Standardisation Initiative (IDDSI), Part I: Quantitative Analysis of IDDSI Performance Among Varied Participants. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Bolus Texture Testing as a Clinical Method for Evaluating Food Oral Processing and Choking Risk: A Pilot Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Objective Evaluation Tool for Texture-Modified Food (OET-TMF): Development of the Tool and Validation. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Intake and Meal Composition of Patients Consuming Texture Modified Diets and Thickened Fluids: A Systematic Review and Meta-Analysis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Older adults' acceptance of ready-to-eat meals in relation to food choice and sensory ability. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Evaluation of a controlled 6 months feeding trial on intake by infants and toddlers fed a high energy-low bulk gruel versus a high energy-high bulk gruel in addition to their habitual home diet. [2018]

12. India pubmed.ncbi.nlm.nih.gov

Formulation and processing of gruels made from local ingredients, thin enough to flow by gravity in enteral tube feeding. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Oral declines and mastication deficiencies cause alteration of food bolus properties. [2018]