Cooling-flavored supplements to help swallowing after acute stroke
Official title: Evaluation of the Perception of Freshness and Swallowing Safety in Stroke Patients With Dysphagia Receiving a Specially Designed Thickened Oral Nutritional Supplement: the Cooling Sensation Safe Deglution Study
Run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · NCT06936501 · Data updated 2026-11-12
This study will test whether refreshing, cooling-flavored high-protein oral supplements help hospitalized adults with post-stroke dysphagia swallow and tolerate nutrition better than traditional flavors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Locations | 1 site (Málaga, Málaga) |
| Status | Recruiting |
| Started | May 19, 2025 |
| Main results expected | January 31, 2026 |
| Study ends | March 30, 2026 |
| Registry record updated | July 1, 2025 |
| Trial ID | NCT06936501 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 hospitalized for acute stroke with V-VST–confirmed dysphagia and judged to be malnourished or at risk who can give informed consent and complete questionnaires are ideal candidates.
✕Probably not a fit
Patients with moderate-to-severe cognitive impairment, advanced dementia, severe psychiatric illness, galactosemia, intolerance to supplement ingredients, or other barriers to understanding or cooperating are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Hospitalized adults with acute stroke and dysphagia confirmed by the V-VST who are at risk of malnutrition receive thickened, high-calorie, high-protein oral nutritional supplements in either traditional (vanilla or strawberry) or refreshing/cooling (mango-peppermint or lemon-mint) flavors by choice. Clinical swallow assessments, intake measures, tolerance observations and patient questionnaires are used to collect data during the hospital stay. The trial compares swallow safety, nutritional intake, and patient acceptance between the two flavor approaches using routine clinical tools and consented participation. Results aim to inform whether a sensory-modified supplement can improve intake and reduce complications in the acute post-stroke period.
Why it matters
Potential benefit: If successful, cooling or refreshing flavors could increase safe oral intake, reduce malnutrition and lower aspiration-related respiratory complications after stroke.
How similar studies have gone: Some prior studies show that sensory stimuli such as cold or sour boluses can speed the swallow reflex and improve safety in people with dysphagia, but using cooling-flavored oral nutritional supplements is a relatively novel approach with limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women over 18 years old. * Currently hospitalized due to an acute stroke. * Confirmed diagnosis of dysphagia through V-VST (Volume-Viscosity Swallow Test). * Ability to collaborate and respond to questionnaire questions and other research tools used in the study. * Malnutrition or risk of malnutrition, requiring a thickened, high-calorie, high-protein ONS, as determined by medical assessment in routine clinical practice. * Voluntary written informed consent to participate in the study. Exclusion Criteria: * Moderate to severe cognitive impairment that interferes with the correct interpretation of the study or its requirements. * Diagnosis of advanced dementia, severe psychiatric illness, or any other central nervous system condition that impairs the patient's comprehension of the study. * Sociocultural, linguistic, intellectual, or other factors that hinder the patient's proper understanding of the study. * Diagnosis of galactosemia. * Intolerance or refusal (for any reason) of oral nutritional supplements. * Requirement for parenteral nutrition or contraindication to oral intake. * Severe active renal, hepatic, or gastrointestinal diseases that contraindicate the use of ONS
Where it's running
-
Hospital Regional Universitario de Málaga
Málaga, Málaga, Spain Recruiting
Study contacts
- Principal investigator: Gabriel Olveira Fuster, PhD, MD — Hospital Regional de Malaga
- Study coordinator: Gabriel Olveira Fuster, PhD, MD
- Email: gabrielm.olveira.sspa@juntadeandalucia.es
- Phone: +34 951290343 / +34 951030117
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.